Regulating Regenerative Medicine
•Download as DOCX, PDF•
0 likes•8 views
In recent years, the field of regenerative medicine has gained significant traction and been pointed to as the future wave of medicine. Regenerative medicine focuses on replacing tissues or organs that have been damaged by disease or other conditions and includes the fields of tissue engineering, cellular therapies, and artificial organs. As part of the agency’s commitment to help bring new and innovative treatment options to patients, the FDA regulates regenerative medicine through its Center for Biologics Evaluation and Research (CBER)...
Report
Share
Report
Share
Recommended
Regulation, ethics and reimbursement of novel biological therapies in Austral...
The document provides an overview of novel biological therapies such as gene therapy, cell therapy, and tissue engineering in Australia. It discusses the regulatory pathways through the Therapeutic Goods Administration (TGA) for approval of these therapies. Clinical trials of novel biological therapies must be submitted through the CTX scheme for approval rather than just notification. Guidelines from the European Medicines Agency are a good resource for requirements for registration and approval of these therapies in Australia. Risks associated with gene therapy include potential for delayed adverse effects, off-target effects, insertional mutagenesis, and immune responses.
Regulatory requirements for drug approval
1. Regulatory requirements for drug approval were introduced after tragic incidents led to deaths, to ensure safety and efficacy of new drugs. Countries have different regulatory agencies that new drugs must be approved by before marketing.
2. The drug development process takes 10-12 years and involves multiple scientific disciplines working together. Non-clinical and clinical trials are conducted to characterize the drug candidate and determine safety and dosing in humans.
3. A New Drug Application contains clinical and manufacturing data submitted to regulatory agencies for review and potential approval to market a new drug. Bioequivalence studies ensure generic drugs have consistent quality, efficacy and safety compared to brand name drugs.
Outsourcing in Clinical Research
Outsourcing is a Cost-effective strategy when used properly and at present is gaining more and more importance. Here's a short presentation about the importance of outsourcing in Clinical research.
Dr. Annette Jones - Complying with California's Senate Bill 27 on Antibiotic ...
Complying with California's Senate Bill 27 on Antibiotic Use in Livestock - Dr. Annette Jones, State Veterinarian and Director, Animal Health and Food Safety Services, California Department of Food and Agriculture, from the 2016 NIAA Antibiotic Symposium - Working Together For Better Solutions, November 1 - 3, 2016, Herndon, Virginia, USA.
More presentations at http://www.swinecast.com/2016-niaa-symposium-antibiotic-use-working-together-for-better-solutions
Drug Regulatory Affairs
This document provides an overview of regulatory affairs for drugs. It defines key terms like regulatory affairs, dossier, CTD, eCTD, DMF, NDA, ANDA, and INDA. It describes the role of regulatory affairs experts in guiding product development according to regulatory requirements, compiling dossiers for submission, and ensuring post-marketing compliance. The document outlines a 10 step process for regulatory product development and regulatory submission preparation. It also discusses quality management systems for regulatory compliance and the role of regulatory affairs in marketing and advertising compliance.
Application for New Drug Discovery (NDD) according to USFDA guidelines
The document discusses the US FDA's process for approving new drug applications (NDAs). The FDA is responsible for ensuring drugs are safe, effective and quality-controlled. Developers must submit clinical data to FDA's Center for Drug Evaluation and Research which reviews the data. If benefits outweigh risks, the drug receives approval. For serious conditions, accelerated approval is possible where post-market studies confirm initial findings. Designations like Fast Track can expedite review of innovative drugs that address unmet needs. A complete NDA includes manufacturing and clinical information. Advisory committees provide recommendations to FDA on approval.
Combination Products
A combination product is defined as a product composed of two or more regulated components (drug, device, biologic) that are combined and produced as a single entity. Combination products may be classified as drugs or devices depending on their principal mechanism of action. Health Canada and the US FDA have policies for classifying combination products and determining which agency regulations apply. The sponsor can request a classification from the agencies, which will consider the product's components and principal mechanism of action.
IND, NDA, ANDA, SNDA
The document discusses Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Supplemental New Drug Applications (SNDAs). It provides details on the purpose and requirements of each application type, including necessary contents, guidelines, and the laws and regulations that govern the FDA drug approval process.
Recommended
Regulation, ethics and reimbursement of novel biological therapies in Austral...
The document provides an overview of novel biological therapies such as gene therapy, cell therapy, and tissue engineering in Australia. It discusses the regulatory pathways through the Therapeutic Goods Administration (TGA) for approval of these therapies. Clinical trials of novel biological therapies must be submitted through the CTX scheme for approval rather than just notification. Guidelines from the European Medicines Agency are a good resource for requirements for registration and approval of these therapies in Australia. Risks associated with gene therapy include potential for delayed adverse effects, off-target effects, insertional mutagenesis, and immune responses.
Regulatory requirements for drug approval
1. Regulatory requirements for drug approval were introduced after tragic incidents led to deaths, to ensure safety and efficacy of new drugs. Countries have different regulatory agencies that new drugs must be approved by before marketing.
2. The drug development process takes 10-12 years and involves multiple scientific disciplines working together. Non-clinical and clinical trials are conducted to characterize the drug candidate and determine safety and dosing in humans.
3. A New Drug Application contains clinical and manufacturing data submitted to regulatory agencies for review and potential approval to market a new drug. Bioequivalence studies ensure generic drugs have consistent quality, efficacy and safety compared to brand name drugs.
Outsourcing in Clinical Research
Outsourcing is a Cost-effective strategy when used properly and at present is gaining more and more importance. Here's a short presentation about the importance of outsourcing in Clinical research.
Dr. Annette Jones - Complying with California's Senate Bill 27 on Antibiotic ...
Complying with California's Senate Bill 27 on Antibiotic Use in Livestock - Dr. Annette Jones, State Veterinarian and Director, Animal Health and Food Safety Services, California Department of Food and Agriculture, from the 2016 NIAA Antibiotic Symposium - Working Together For Better Solutions, November 1 - 3, 2016, Herndon, Virginia, USA.
More presentations at http://www.swinecast.com/2016-niaa-symposium-antibiotic-use-working-together-for-better-solutions
Drug Regulatory Affairs
This document provides an overview of regulatory affairs for drugs. It defines key terms like regulatory affairs, dossier, CTD, eCTD, DMF, NDA, ANDA, and INDA. It describes the role of regulatory affairs experts in guiding product development according to regulatory requirements, compiling dossiers for submission, and ensuring post-marketing compliance. The document outlines a 10 step process for regulatory product development and regulatory submission preparation. It also discusses quality management systems for regulatory compliance and the role of regulatory affairs in marketing and advertising compliance.
Application for New Drug Discovery (NDD) according to USFDA guidelines
The document discusses the US FDA's process for approving new drug applications (NDAs). The FDA is responsible for ensuring drugs are safe, effective and quality-controlled. Developers must submit clinical data to FDA's Center for Drug Evaluation and Research which reviews the data. If benefits outweigh risks, the drug receives approval. For serious conditions, accelerated approval is possible where post-market studies confirm initial findings. Designations like Fast Track can expedite review of innovative drugs that address unmet needs. A complete NDA includes manufacturing and clinical information. Advisory committees provide recommendations to FDA on approval.
Combination Products
A combination product is defined as a product composed of two or more regulated components (drug, device, biologic) that are combined and produced as a single entity. Combination products may be classified as drugs or devices depending on their principal mechanism of action. Health Canada and the US FDA have policies for classifying combination products and determining which agency regulations apply. The sponsor can request a classification from the agencies, which will consider the product's components and principal mechanism of action.
IND, NDA, ANDA, SNDA
The document discusses Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Supplemental New Drug Applications (SNDAs). It provides details on the purpose and requirements of each application type, including necessary contents, guidelines, and the laws and regulations that govern the FDA drug approval process.
Post marketing surveilance, outsourcing BA and BE to CRO
This document discusses post-marketing surveillance, outsourcing bioavailability and bioequivalence studies to contract research organizations. It provides an introduction to post-marketing surveillance, describing its role in monitoring drug safety after market approval. A brief history is given of pivotal drug safety issues that led to the establishment of formal post-marketing surveillance systems. Common sources of post-marketing information are also outlined. The document defines outsourcing, bioavailability, bioequivalence, and contract research organizations. It explains how outsourcing is used to reduce costs and improve efficiency through utilizing external partners for certain studies and services.
Drug regulatory affairs - 1
Regulatory affairs professionals play a crucial role in ensuring pharmaceutical products meet regulatory standards for safety, efficacy and quality. They provide strategic guidance to various departments on regulatory requirements and work to obtain approvals from regulatory authorities. Key responsibilities include filing product registrations, tracking legal changes, and facilitating clinical trials and product approvals. Regulatory affairs has become increasingly important given historical issues that prompted stronger drug regulations to protect public health.
Outsourcing bioavailibility and bioequivalence studies to contract research
This document defines a contract research organization (CRO) and outlines their goals and services. CROs provide outsourced clinical research services to the pharmaceutical industry. Their services include clinical trials, preclinical research, pharmacovigilance, and biological assay development. Companies outsource to CROs due to lack of in-house capacity, skills, or to control costs. When selecting a CRO, companies should assess their clinical, bioanalytical, and pharmacokinetic capabilities. They should also qualify CRO sites to ensure compliance with Good Clinical Practices and laboratory standards.
cmc [ chemistry manufacturing control ]
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
Regulatory requirements for drug approval - industrial pharmacy II
Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
Globalization Of Clinical Trials 2010 Josep M. Badenas
Globalization of clinical trials can help bring drugs to market more quickly. While the majority of research and development spending still occurs in developed countries like the US and Western Europe, emerging markets are playing a larger role in global drug development. Countries like India and China provide opportunities for cost-effective clinical trials due to their large patient populations and improving healthcare infrastructures and regulations. However, conducting trials globally also presents challenges around cultural and medical practice differences that need to be addressed.
RCM Services
RCM assists life science organizations in achieving regulatory compliance by providing validation services from design through decommissioning using proprietary methodologies and qualified staff. Their services address validation of systems, facilities, equipment, and processes according to FDA requirements and international regulations. They have expertise in a broad range of validation areas including computer systems, laboratory instruments, manufacturing execution systems, and quality management systems. RCM supports clients' compliance needs with services for validation, qualification, implementation, and pharmacovigilance.
Drug Regulatory Affairs- 2
1) Regulatory affairs professionals play important roles in coordinating scientific efforts with regulatory needs throughout a product's lifecycle. They help companies reduce time to market and maximize resources.
2) Key responsibilities include evaluating marketing applications, issuing approvals, developing guidelines, inspecting sites, and monitoring drug safety.
3) In the pharmaceutical industry, regulatory affairs professionals develop regulatory strategies, prepare applications, maintain relationships with health authorities, and ensure compliance.
Clinical Research
Clinical research involves systematically studying new drugs in human subjects to discover and verify their safety, efficacy, clinical effects, and adverse reactions. Careers in clinical research include clinical research associate, clinical research coordinator, clinical investigator, medical advisor, biostatistician, data manager, clinical trial auditor, medical writer, and clinical research trainer. Clinical research work involves clinical trial processes and operations, clinical data management, medical writing, pharmacovigilance, regulatory affairs, and quality assurance.
FIXED DOSE COMBINATIONS REGULATIONS IN INDIA AND A CASE STUDY ON THE TOP SELL...
FIXED DOSE COMBINATIONS REGULATIONS IN INDIA AND A CASE STUDY ON THE TOP SELL...JAYA PRAKASH VELUCHURI
This document summarizes a review of clinical trial evidence for metformin fixed-dose combinations (FDCs) used to treat type 2 diabetes in India. The review found:
- Only 25 relevant clinical trials were identified, with most comparing metformin FDCs to monotherapy rather than the individual components.
- None of the trials met all of the WHO's criteria for size, duration, design, and assessing adverse reactions.
- Only 3 trials were conducted in India, with one including just 101 patients over 2 months.
- Despite a lack of robust evidence, over 50 metformin FDCs have been approved in India. The document calls for Indian regulators to make their review and approval evidence public, and to strengthen clinical trial requirementsBest techniques to control Genotoxities and impact of ICH M7 guideline
This document discusses best techniques to control genotoxic impurities according to the ICH M7 guideline. It covers the scope and principles of ICH M7, including risk assessment of potential genotoxic impurities in drug substances and products. It also discusses classification of impurities, acceptable intake levels, control options, and retrospective application of ICH M7 to marketed products. The goal is to limit risk from genotoxic impurities to virtually safe levels through appropriate testing, control, and documentation strategies.
Drug development process
The document discusses the process of new drug development, which involves several lengthy and costly stages. In preclinical testing, potential drug candidates are screened in animal and laboratory testing to evaluate toxicity, safety, and efficacy. If successful, compounds enter clinical trials involving 4 phases with human subjects to further assess safety and effectiveness. Only about 1-2% of initially investigated compounds ultimately result in an approved drug. The entire process from discovery to regulatory approval can take over 12 years and cost over $1 billion. Rigorous testing and regulatory standards aim to bring only safe and effective drugs to market.
Post marketing surveillance out sourcing bioavalability and bioequevalenceto
Outsourcing is hiring an outside party to perform services traditionally done in-house like bioavailability and bioequivalence studies. Bioavailability measures the amount and rate of drug reaching systemic circulation. Bioequivalence denotes that two dosage forms release drug at the same rate and to the same extent. Contract research organizations (CROs) provide outsourced pharmaceutical research services to support clinical trials and drug registration requirements.
The Trials and Tribulations of Combination Product Development
Presented at the Sept. 7, 2010 Bio2Device group meeting, this talk focuses on the problems and solutions of combination product (primarly drug/medical device) development.
Pharmacovigilance audit
A pharmacovigilance audit involves several key steps: (1) opening meetings with relevant personnel, (2) document reviews and interviews to evaluate processes for safety data collection, case assessment, and reporting, (3) analyzing data to identify potential safety signals, and (4) closing meetings to discuss preliminary findings. The audit aims to verify that the pharmacovigilance system meets legal requirements for drug safety monitoring and ensure any issues from previous inspections have been addressed. Regular audits are important for regulatory compliance and identifying areas for improvement in pharmacovigilance practices.
Healthcare &Pharmaceutical
The document discusses the healthcare and pharmaceutical industries. The healthcare industry provides goods and services for curative, preventive, rehabilitative, and palliative care and includes medical equipment, supplies, and healthcare services like hospitals and nursing homes. The pharmaceutical industry develops, produces, and markets drugs and deals in generic and brand medications. Some reputable healthcare companies mentioned are Sanofi, Hoffman la Roche, Johnson and Johnson, and Novartis, while reputable pharmaceutical companies include Catalent MSP, DuPont, BASF, and Amgen. Important roles in the industries include scientist, chemist, laboratory technician, clinical trials manager, nurse, and research associate.
Nda
The document discusses the requirements for a New Drug Application (NDA) submitted to the FDA for approval of a new pharmaceutical product. An NDA must provide extensive data on the chemistry, manufacturing, animal and human clinical studies of the drug to allow the FDA to determine if the drug is safe, effective and of adequate quality for approval. Guidance documents provide recommendations to applicants on the content and format of an NDA to streamline the review process.
Regulatory Affairs 2010
Speid and Associates is a Regulatory Affairs and Drug Development Consultancy Company. (Slides produced in 2010)
FDA drug approval and review process
The drug development and review process involves several stages. Drugs are first tested on animals to assess safety before human clinical trials. Clinical trials involve 3 phases testing on increasingly large groups of human subjects to evaluate safety, efficacy, and optimal dosage. If results are promising, drug sponsors submit a New Drug Application to the FDA including all trial data. The FDA thoroughly reviews the application over 6-10 months before approving the drug or requesting more information. Post-approval, the FDA continues monitoring the drug for safety issues and requires further studies if needed.
Non clinical drug development
This document provides an overview of non-clinical (pre-clinical) drug development. It discusses key terminology used in pre-clinical development like CTD, NOAEL, IND, NCE, NDA. It explains that pre-clinical development spans the gap between discovery and first-in-human clinical trials, with the goal of identifying the safest lead candidate and building a scientific foundation for clinical trials. The document outlines the main components of pre-clinical development, including pharmacology studies, safety pharmacology, PK/ADME studies, toxicology studies, and starting dose selection. It notes that pre-clinical studies must adhere to ICH GLP guidelines. The CTD pyramid is also discussed as the common
WHITE PAPER: What’s Next in US Payor Communications: The Impact of FDA's Prop...
This white paper from ApotheCom discusses new FDA guidance on communicating healthcare economic information to payors as outlined in the 21st Century Cures Act. Key points:
- The Cures Act establishes guidelines for communicating information on the economic impact of drugs and devices to payors.
- In response, FDA issued draft guidance to clarify what can be communicated about approved drugs to payors.
- The guidance defines payors as including formulary committees and outlines standards for ensuring communicated analyses are scientifically valid and relate to approved drug indications.
- The changes aim to increase transparency while allowing industry to demonstrate treatment value to payors.
Fda Cms Pro Industry Initiatives
The document discusses several recent "pro-industry" initiatives by the FDA and CMS that are intended to improve responsiveness to industry but have disappointed many companies. It outlines initiatives by each agency, as well as two joint initiatives, including improved information sharing between the agencies. However, the document notes that industry remains doubtful about the initiatives due to ongoing costs, uncertainty, and limitations of some programs. Barriers to successful implementation of the initiatives include limited agency budgets, staffing challenges, and lack of stable leadership.
More Related Content
What's hot
Post marketing surveilance, outsourcing BA and BE to CRO
This document discusses post-marketing surveillance, outsourcing bioavailability and bioequivalence studies to contract research organizations. It provides an introduction to post-marketing surveillance, describing its role in monitoring drug safety after market approval. A brief history is given of pivotal drug safety issues that led to the establishment of formal post-marketing surveillance systems. Common sources of post-marketing information are also outlined. The document defines outsourcing, bioavailability, bioequivalence, and contract research organizations. It explains how outsourcing is used to reduce costs and improve efficiency through utilizing external partners for certain studies and services.
Drug regulatory affairs - 1
Regulatory affairs professionals play a crucial role in ensuring pharmaceutical products meet regulatory standards for safety, efficacy and quality. They provide strategic guidance to various departments on regulatory requirements and work to obtain approvals from regulatory authorities. Key responsibilities include filing product registrations, tracking legal changes, and facilitating clinical trials and product approvals. Regulatory affairs has become increasingly important given historical issues that prompted stronger drug regulations to protect public health.
Outsourcing bioavailibility and bioequivalence studies to contract research
This document defines a contract research organization (CRO) and outlines their goals and services. CROs provide outsourced clinical research services to the pharmaceutical industry. Their services include clinical trials, preclinical research, pharmacovigilance, and biological assay development. Companies outsource to CROs due to lack of in-house capacity, skills, or to control costs. When selecting a CRO, companies should assess their clinical, bioanalytical, and pharmacokinetic capabilities. They should also qualify CRO sites to ensure compliance with Good Clinical Practices and laboratory standards.
cmc [ chemistry manufacturing control ]
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
Regulatory requirements for drug approval - industrial pharmacy II
Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
Globalization Of Clinical Trials 2010 Josep M. Badenas
Globalization of clinical trials can help bring drugs to market more quickly. While the majority of research and development spending still occurs in developed countries like the US and Western Europe, emerging markets are playing a larger role in global drug development. Countries like India and China provide opportunities for cost-effective clinical trials due to their large patient populations and improving healthcare infrastructures and regulations. However, conducting trials globally also presents challenges around cultural and medical practice differences that need to be addressed.
RCM Services
RCM assists life science organizations in achieving regulatory compliance by providing validation services from design through decommissioning using proprietary methodologies and qualified staff. Their services address validation of systems, facilities, equipment, and processes according to FDA requirements and international regulations. They have expertise in a broad range of validation areas including computer systems, laboratory instruments, manufacturing execution systems, and quality management systems. RCM supports clients' compliance needs with services for validation, qualification, implementation, and pharmacovigilance.
Drug Regulatory Affairs- 2
1) Regulatory affairs professionals play important roles in coordinating scientific efforts with regulatory needs throughout a product's lifecycle. They help companies reduce time to market and maximize resources.
2) Key responsibilities include evaluating marketing applications, issuing approvals, developing guidelines, inspecting sites, and monitoring drug safety.
3) In the pharmaceutical industry, regulatory affairs professionals develop regulatory strategies, prepare applications, maintain relationships with health authorities, and ensure compliance.
Clinical Research
Clinical research involves systematically studying new drugs in human subjects to discover and verify their safety, efficacy, clinical effects, and adverse reactions. Careers in clinical research include clinical research associate, clinical research coordinator, clinical investigator, medical advisor, biostatistician, data manager, clinical trial auditor, medical writer, and clinical research trainer. Clinical research work involves clinical trial processes and operations, clinical data management, medical writing, pharmacovigilance, regulatory affairs, and quality assurance.
FIXED DOSE COMBINATIONS REGULATIONS IN INDIA AND A CASE STUDY ON THE TOP SELL...
FIXED DOSE COMBINATIONS REGULATIONS IN INDIA AND A CASE STUDY ON THE TOP SELL...JAYA PRAKASH VELUCHURI
This document summarizes a review of clinical trial evidence for metformin fixed-dose combinations (FDCs) used to treat type 2 diabetes in India. The review found:
- Only 25 relevant clinical trials were identified, with most comparing metformin FDCs to monotherapy rather than the individual components.
- None of the trials met all of the WHO's criteria for size, duration, design, and assessing adverse reactions.
- Only 3 trials were conducted in India, with one including just 101 patients over 2 months.
- Despite a lack of robust evidence, over 50 metformin FDCs have been approved in India. The document calls for Indian regulators to make their review and approval evidence public, and to strengthen clinical trial requirementsBest techniques to control Genotoxities and impact of ICH M7 guideline
This document discusses best techniques to control genotoxic impurities according to the ICH M7 guideline. It covers the scope and principles of ICH M7, including risk assessment of potential genotoxic impurities in drug substances and products. It also discusses classification of impurities, acceptable intake levels, control options, and retrospective application of ICH M7 to marketed products. The goal is to limit risk from genotoxic impurities to virtually safe levels through appropriate testing, control, and documentation strategies.
Drug development process
The document discusses the process of new drug development, which involves several lengthy and costly stages. In preclinical testing, potential drug candidates are screened in animal and laboratory testing to evaluate toxicity, safety, and efficacy. If successful, compounds enter clinical trials involving 4 phases with human subjects to further assess safety and effectiveness. Only about 1-2% of initially investigated compounds ultimately result in an approved drug. The entire process from discovery to regulatory approval can take over 12 years and cost over $1 billion. Rigorous testing and regulatory standards aim to bring only safe and effective drugs to market.
Post marketing surveillance out sourcing bioavalability and bioequevalenceto
Outsourcing is hiring an outside party to perform services traditionally done in-house like bioavailability and bioequivalence studies. Bioavailability measures the amount and rate of drug reaching systemic circulation. Bioequivalence denotes that two dosage forms release drug at the same rate and to the same extent. Contract research organizations (CROs) provide outsourced pharmaceutical research services to support clinical trials and drug registration requirements.
The Trials and Tribulations of Combination Product Development
Presented at the Sept. 7, 2010 Bio2Device group meeting, this talk focuses on the problems and solutions of combination product (primarly drug/medical device) development.
Pharmacovigilance audit
A pharmacovigilance audit involves several key steps: (1) opening meetings with relevant personnel, (2) document reviews and interviews to evaluate processes for safety data collection, case assessment, and reporting, (3) analyzing data to identify potential safety signals, and (4) closing meetings to discuss preliminary findings. The audit aims to verify that the pharmacovigilance system meets legal requirements for drug safety monitoring and ensure any issues from previous inspections have been addressed. Regular audits are important for regulatory compliance and identifying areas for improvement in pharmacovigilance practices.
Healthcare &Pharmaceutical
The document discusses the healthcare and pharmaceutical industries. The healthcare industry provides goods and services for curative, preventive, rehabilitative, and palliative care and includes medical equipment, supplies, and healthcare services like hospitals and nursing homes. The pharmaceutical industry develops, produces, and markets drugs and deals in generic and brand medications. Some reputable healthcare companies mentioned are Sanofi, Hoffman la Roche, Johnson and Johnson, and Novartis, while reputable pharmaceutical companies include Catalent MSP, DuPont, BASF, and Amgen. Important roles in the industries include scientist, chemist, laboratory technician, clinical trials manager, nurse, and research associate.
Nda
The document discusses the requirements for a New Drug Application (NDA) submitted to the FDA for approval of a new pharmaceutical product. An NDA must provide extensive data on the chemistry, manufacturing, animal and human clinical studies of the drug to allow the FDA to determine if the drug is safe, effective and of adequate quality for approval. Guidance documents provide recommendations to applicants on the content and format of an NDA to streamline the review process.
Regulatory Affairs 2010
Speid and Associates is a Regulatory Affairs and Drug Development Consultancy Company. (Slides produced in 2010)
FDA drug approval and review process
The drug development and review process involves several stages. Drugs are first tested on animals to assess safety before human clinical trials. Clinical trials involve 3 phases testing on increasingly large groups of human subjects to evaluate safety, efficacy, and optimal dosage. If results are promising, drug sponsors submit a New Drug Application to the FDA including all trial data. The FDA thoroughly reviews the application over 6-10 months before approving the drug or requesting more information. Post-approval, the FDA continues monitoring the drug for safety issues and requires further studies if needed.
Non clinical drug development
This document provides an overview of non-clinical (pre-clinical) drug development. It discusses key terminology used in pre-clinical development like CTD, NOAEL, IND, NCE, NDA. It explains that pre-clinical development spans the gap between discovery and first-in-human clinical trials, with the goal of identifying the safest lead candidate and building a scientific foundation for clinical trials. The document outlines the main components of pre-clinical development, including pharmacology studies, safety pharmacology, PK/ADME studies, toxicology studies, and starting dose selection. It notes that pre-clinical studies must adhere to ICH GLP guidelines. The CTD pyramid is also discussed as the common
What's hot (20)
Post marketing surveilance, outsourcing BA and BE to CRO
Post marketing surveilance, outsourcing BA and BE to CRO
Outsourcing bioavailibility and bioequivalence studies to contract research
Outsourcing bioavailibility and bioequivalence studies to contract research
Regulatory requirements for drug approval - industrial pharmacy II
Regulatory requirements for drug approval - industrial pharmacy II
Globalization Of Clinical Trials 2010 Josep M. Badenas
Globalization Of Clinical Trials 2010 Josep M. Badenas
FIXED DOSE COMBINATIONS REGULATIONS IN INDIA AND A CASE STUDY ON THE TOP SELL...
FIXED DOSE COMBINATIONS REGULATIONS IN INDIA AND A CASE STUDY ON THE TOP SELL...
Best techniques to control Genotoxities and impact of ICH M7 guideline
Best techniques to control Genotoxities and impact of ICH M7 guideline
Post marketing surveillance out sourcing bioavalability and bioequevalenceto
Post marketing surveillance out sourcing bioavalability and bioequevalenceto
The Trials and Tribulations of Combination Product Development
The Trials and Tribulations of Combination Product Development
Similar to Regulating Regenerative Medicine
WHITE PAPER: What’s Next in US Payor Communications: The Impact of FDA's Prop...
This white paper from ApotheCom discusses new FDA guidance on communicating healthcare economic information to payors as outlined in the 21st Century Cures Act. Key points:
- The Cures Act establishes guidelines for communicating information on the economic impact of drugs and devices to payors.
- In response, FDA issued draft guidance to clarify what can be communicated about approved drugs to payors.
- The guidance defines payors as including formulary committees and outlines standards for ensuring communicated analyses are scientifically valid and relate to approved drug indications.
- The changes aim to increase transparency while allowing industry to demonstrate treatment value to payors.
Fda Cms Pro Industry Initiatives
The document discusses several recent "pro-industry" initiatives by the FDA and CMS that are intended to improve responsiveness to industry but have disappointed many companies. It outlines initiatives by each agency, as well as two joint initiatives, including improved information sharing between the agencies. However, the document notes that industry remains doubtful about the initiatives due to ongoing costs, uncertainty, and limitations of some programs. Barriers to successful implementation of the initiatives include limited agency budgets, staffing challenges, and lack of stable leadership.
Market access medical devices-white paper
This document discusses challenges and potential solutions related to market access for medical devices. Some key challenges include creating and communicating value to stakeholders, varied decision-making criteria across countries, technological evolution outpacing regulation updates, resource constraints in healthcare systems, lack of stakeholder engagement, and lack of evidence on economic value. Potential solutions proposed are focusing on health technology assessment processes, utilizing HTA groups as knowledge resources, reforming regulatory processes, increasing stakeholder involvement, using real-world data to drive device design and adoption, and effectively communicating value to end-users. Future trends may include increased combination products that integrate drugs, devices and/or biologics.
Market access medical devices white paper
This document discusses challenges and potential solutions related to market access for medical devices. Some key challenges include creating and communicating value to stakeholders, varied decision-making criteria across countries, technological evolution outpacing regulatory updates, resource constraints in healthcare systems, lack of stakeholder engagement, and lack of evidence on economic value. Potential solutions proposed are focusing on health technology assessment processes, utilizing HTA groups as resources, reforming regulatory processes, increasing stakeholder involvement, using real-world data to drive device design and adoption, and effectively communicating value to end-users. Future trends may include increased combination products that integrate drugs, devices and/or biologics.
What is FDA?
Details about Food and Drugs Administration (FDA)
Read More - http://www.pharmaguideline.com/2015/12/top-5-tips-for-fda-inspection.html
Healthcare QualityPolicy and LawChapter 121Cha
Healthcare Quality
Policy and Law
Chapter 12
1
Chapter Overview
(1 of 2)
Discusses licensure and accreditation in the context of healthcare quality
Describes the scope and causes of medical errors
Describes the meaning and evolution of the medical professional standard of care
Identifies and explains certain state-level legal theories under which healthcare professionals and entities can be held liable for medical negligence
Chapter Overview
(2 of 2)
Explains how federal employee benefits law often preempts medical negligence lawsuits against insurers and managed care organizations
Describes recent efforts to measure and incentivize high-quality health care
Quality Control Through
Licensing and Accreditation
(1 of 3)
Licensing of healthcare professionals and institutions is an important function of state law, as it filters out those who may not have the requisite knowledge or skills to practice medicine
State licensure laws define the qualifications required to become licensed and the standards that must be met for purposes of maintaining and renewing licenses
Quality Control Through
Licensing and Accreditation
(2 of 3)
Historically, licensing has been used in the promotion of healthcare quality in only the bluntest sense. This is because the only method by which to promote quality through licensure is the granting or denial of the license to practice medicine—no real middle ground.
Private professional and industry ethical and practice standards exist, though their effect on day-to-day quality is debatable.
State licensing schemes were designed not with healthcare quality per se in mind, but rather with an eye toward protecting the medical professions from unscrupulous or incompetent providers and bad publicity.
5
Quality Control Through
Licensing and Accreditation
(3 of 3)
Licensure plays an important role in defining the permissible “scope of practice” of the various types of healthcare providers.
It is one thing for state legislators to define the meaning of practice for various broad medical fields, but quite another for legislators to define, for example, the lawful activities of doctors as compared to physician assistants as compared to nurses.
6
Medical Errors
(1 of 3)
Although medical errors are not a new problem, framing the issue as a public health problem is a relatively new phenomenon.
Overall, more people die each year from medical errors than from motor vehicle accidents, breast cancer, or AIDS.
Medical Errors
(2 of 3)
Causes of medical errors may include the failure to complete an intended medical course of action, implementation of the wrong course of action, use of faulty equipment or products in effectuating a course of action, failure to stay abreast of one’s field of medical practice, health professional inattentiveness, the fact that optimal treatments for many illnesses are not yet known, and the culture of medicine itself.
Medical Errors
(3 of 3)
Policy makers have begun shifting their ...
Global Medical Cures™ | Paving way for Personalized Medicine (2013)
Global Medical Cures™ | Paving way for Personalized Medicine (2013)
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...
Regulatory compliance is a crucial aspect of conducting clinical research, ensuring that studies meet the requirements and standards set by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and other relevant bodies. Here are some key points to navigate regulatory compliance in clinical research:
Familiarize Yourself with Applicable Regulations: Stay updated on the relevant regulations and guidelines that govern clinical research, including FDA regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and local regulatory requirements. Understand the specific regulations that apply to your study, such as those related to investigational new drugs (IND) or investigational device exemptions (IDE).
Obtain Institutional Review Board (IRB) Approval: IRBs play a crucial role in ensuring the protection of human subjects in research. Before initiating a clinical trial, obtain IRB approval by submitting a detailed study protocol, informed consent documents, and other required materials. IRBs review the study's scientific merit, ethical considerations, and compliance with regulations.
Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application: If your clinical research involves the use of investigational drugs or devices, you may need to submit an IND or IDE application to the FDA. These applications provide detailed information on the investigational product, its safety, efficacy, manufacturing processes, and proposed study design.
Good Clinical Practice (GCP) Guidelines: GCP guidelines provide a framework for the conduct of clinical research to ensure data integrity and participant protection. Adhere to GCP principles, including informed consent, protocol adherence, accurate documentation, and appropriate monitoring and reporting of adverse events.
Adverse Event Reporting: Monitor and report adverse events occurring during the study promptly. Follow the FDA's requirements for safety reporting, including expedited reporting of serious and unexpected adverse events. Maintain accurate and complete records of adverse events and their follow-up actions.
Data Integrity and Documentation: Ensure the integrity, accuracy, and traceability of study data. Implement robust data management practices, including proper documentation, source data verification, and secure storage of study documents. Follow regulatory requirements for data retention, including archiving study records for the required period.
Audits and Inspections: Be prepared for audits and inspections by regulatory agencies. Maintain organized and easily accessible study documentation, including study protocols, informed consent forms, case report forms, and correspondence with IRBs and regulatory agencies. Cooperate with auditors or inspectors and address any identified deficiencies or findings promptly.
Directed Project
This document discusses regulatory inefficiencies surrounding companion diagnostics and laboratory developed tests (LDTs) in the United States. It uses the case study of Genentech's drug MPDL3280A and its companion diagnostic to show that the FDA thoroughly regulates companion diagnostics but provides no oversight of clinical validity for LDTs. This allows multiple competing diagnostic tests to be used without proof of efficacy. The document also compares healthcare systems and technology assessment processes in the US, UK, and France to illustrate decentralized decision making in the US compared to centralized bodies in other countries.
Discovery of Drug and Introduction to Clinical Trial_Katalyst HLS
Introduction to Discovery of Drug and Introduction to Clinical Trials in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Ucm358301
This document provides guidance on four FDA programs that aim to expedite development and review of new drugs to treat serious or life-threatening conditions with unmet medical need. The four programs are: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation. The guidance describes the qualifying criteria and features of each program, and provides an overview of general considerations for manufacturing, nonclinical studies, clinical inspections, and companion diagnostics. It aims to serve as a single resource on the policies and procedures for these expedited programs.
Unique Device Identification and GS1: Defining Elements in the Future of Glob...
This white paper, as the title suggests, is about new national and international mandates for a global standard to be used
in the Unique Device Identification (UDI) of medical devices and other healthcare products. It examines the global trading
opportunities, on an enormous scale, that can be captured by early adopters or forfeited by default by those who wait,
dismiss the idea, or discount the powerful market and competitive forces that UDI developments are driving. Also offered
is a starting blueprint for regulatory compliance professionals, packaging engineers, C-suite executives and manufacturing experts who agree the time to start meeting the UDI opportunity has clearly arrived.
NDA_ANDA_IND.docx
The document provides an overview of the requirements for a New Drug Application (NDA) submitted to the FDA for approval of a new pharmaceutical. An NDA must include extensive information on clinical trials demonstrating safety and efficacy, chemistry and manufacturing, and product labeling. It follows studies conducted under an Investigational New Drug application and provides all relevant data to allow the FDA to determine if the drug is safe, effective and manufactured properly. The review process involves evaluation by experts in areas like clinical research, chemistry and statistics. Guidance documents provide detailed requirements for the format and content of each section of an NDA.
The Pharma & ACO Relationship
The document provides an overview of Accountable Care Organizations (ACOs) and their relationship to the pharmaceutical industry. It discusses the goals of ACOs in improving quality of care while reducing costs. While initial results of ACOs are mixed, with some evidence of cost savings and improved quality, establishing the infrastructure has incurred significant start-up costs. The document also reviews the current pharmaceutical landscape and identifies opportunities for collaboration between ACOs and pharmaceutical companies, such as reducing hospital readmissions through better treatment adherence and education.
Ind by pankaj
INTRODUCTION
IND TYPES
IND CATEGORIES
THE IND APPLICATION MUST CONTAIN INFORMATION IN THREE BROAD AREA
THE REGULATORY ENVIRONMENT AND FDA ROLE
LIST OF IMPORTANT SECTIONS
GENERAL PRINCIPLES
INVESTIGATIONAL NEW DRUG GUIDANCE AND PLANNING
FDA FORM 1571
FDA FORM 1572
FDA FORM 3674
SUBMITTING AN IND
FOLLOWING RECEIPT OF IND BY THE FDA
RESPONDING TO A CLINICAL HOLD
REGULATORY REQUIREMENTS FOR AN IND DURING STUDY AND AT COMPLETION
PROTOCOL AMENDMENTS (21 CFR 312.30)
INFORMATION AMENDMENTS (21 CFR 312.31)
SAFETY REPORTS (21 CFR 312.32)
ANNUAL REPORTS (21 CFR 312.33)
WITHDRAWAL, TERMINATION, AND INACTIVATION
MONITORING RESPONSIBILITIES FOR SPONSOR-INVESTIGATORS
MHRA and USFDA simultaneously data
The document summarizes regulatory affairs for the MHRA and USFDA. It discusses the history and roles of the MHRA in regulating clinical trials, licensing products, and enforcing regulations in the UK. It then outlines the development process for new drugs from discovery through licensing. Finally, it provides an introduction to the USFDA, covering its definition, history, mission, organization, functions, and products regulated.
FDA - General Wellness: Policy for Low Risk Devices
FDA - General Wellness: Policy for Low Risk Devices
Draft Guidance for Industry and Food and Drug Administration
Staff
FDA’s drug review process
The document summarizes FDA's drug review process. Key points:
1. FDA's Center for Drug Evaluation and Research (CDER) ensures drugs marketed in the US are safe and effective. CDER reviews new drug applications but does not test drugs itself.
2. Developing a new drug involves preclinical testing, clinical trials in 3 phases with increasing number of participants, and submitting a New Drug Application for FDA review.
3. The FDA review process evaluates whether clinical trials demonstrate a drug's safety and effectiveness for its intended use. If approved, the FDA continues monitoring the drug for safety after market.
Drug and Device Combinations- The Leadership Challenge
- Over a decade ago, major pharmaceutical companies owned medical device divisions but operated them autonomously with little synergy between the two. This led most pharmaceutical companies to sell their device divisions.
- Recently, some life sciences companies have shifted strategy to developing drug-device combination products, driven by the success of drug-eluting stents. Key examples are drug-eluting stents from Johnson & Johnson and Boston Scientific.
- For companies developing drug-device combinations, effectively executing this strategy requires collaboration between key functions like regulatory affairs, R&D, and manufacturing that have expertise in both drugs and devices. However, talent with experience in both fields is extremely limited.
Accelerating Bio-Pharma's Marketing Transformation
Here's what bio-pharma organizations need to know when transforming the promotional material review and approval process from a transactional requirement to a competitive advantage.
Similar to Regulating Regenerative Medicine (20)
WHITE PAPER: What’s Next in US Payor Communications: The Impact of FDA's Prop...
WHITE PAPER: What’s Next in US Payor Communications: The Impact of FDA's Prop...
Global Medical Cures™ | Paving way for Personalized Medicine (2013)
Global Medical Cures™ | Paving way for Personalized Medicine (2013)
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...
Discovery of Drug and Introduction to Clinical Trial_Katalyst HLS
Discovery of Drug and Introduction to Clinical Trial_Katalyst HLS
Unique Device Identification and GS1: Defining Elements in the Future of Glob...
Unique Device Identification and GS1: Defining Elements in the Future of Glob...
FDA - General Wellness: Policy for Low Risk Devices
FDA - General Wellness: Policy for Low Risk Devices
Drug and Device Combinations- The Leadership Challenge
Drug and Device Combinations- The Leadership Challenge
Accelerating Bio-Pharma's Marketing Transformation
Accelerating Bio-Pharma's Marketing Transformation
More from EMMAIntl
Cartilage Regeneration Techniques
Two cartilage regeneration techniques are briefly covered: Autologous Chondrocyte Implantation (ACI) and Autologous Matrix-Induced Chondrogenesis (AMIC). ACI involves taking cartilage cells from a non-load bearing area, multiplying them in a lab, and re-injecting them into damaged cartilage in two surgeries. AMIC requires only one surgery - the damaged cartilage is removed, the area is stimulated with microfractures, and a collagen membrane placed over the site promotes new cartilage growth from stem cells. These techniques and bio-scaffold technologies offer potential long-term solutions for cartilage conditions and regeneration of original cartilage properties.
Stability Testing of Pharmaceuticals and Supplements
Whether you are working on a prescription drug, over-the-counter (OTC) drug, or even a dietary supplement, stability testing is required depending on the location of registration and agencies involved in its approval. Stability testing is the method of testing a product's safety, efficacy, and chemical composition after a set period...
Intolerance vs. Allergy
Millions in the United States alone have an allergic condition, with many of these allergies being related to food. According to the Food Allergy Research & Education organization (FARE) 32 million Americans have food allergies. Of those 32 million, 200,000 require emergency medical care for allergic reactions from those foods. A common misconception is that food intolerance is a food allergy when in actuality that is its own unique category...
Material Science in MedTech
The field of biomedical engineering is a new, widely researched, and well-funded industry that aims to tackle problems in medicine and health by providing engineered solutions. These solutions might be delivered in the form of electrical hardware, chemicals, or even software. Given the extensive range of applications that exist in the medical device industry, the field is continuously accelerating its innovations in technology via an abundance of research and innovation outlets in countless interrelated fields. One of the many fields that are fundamentally fueling the growth of the biomedical industry is material science...
Investigating Ketamine for Parkinson’s Disease
In May 2021, the FDA approved an Investigational New Drug (IND) application from PharmaTher Holdings Ltd., to proceed with a Phase Two clinical trial. PharmaTher Holdings Ltd. is a psychedelics biotech organization that focuses on research and development, and commercialization of psychedelics to treat pain and neurological disorders, and mental illnesses. This company is headquartered in Vancouver, Canada...
Aduhelm, an Accelerated Approval for Alzheimer’s
Alzheimer’s disease is the most common cause of dementia, especially in patients aged 65 and older1. Alzheimer’s disease is a neurodegenerative disease that has a direct correlation to age: as age increases, the likelihood of developing Alzheimer’s increases as well. Alzheimer’s has long been a subject of discussion in the pharmaceutical industries and, until the FDA’s recent accelerated approval of Aduhelm earlier this month, the most recent treatment approved for Alzheimer’s was in 2003, almost two decades ago. The FDA’s approval of Aduhelm represents the first-of-its-kind treatment and is the first therapy that aims to interrupt the underlying physiological pathway of Alzheimer’s, rather than simply attempt to treat its symptoms...
World Blood Donor Day 2021
Every June 14th, the World Health Organization (WHO) hosts World Blood Donor Day to raise awareness all over the globe for how crucial the need for safe blood is in the healthcare industry. In the US and Canada alone, 43,000 pints of blood are used each day for life-saving procedures and treatments...
New COVID-19 Vaccine
Starting in Summer 2021, a new type of COVID vaccine could be available. Known as a protein subunit vaccine, this vaccine contains a spike protein that the other three vaccines are missing. The other vaccines, Pfizer, Moderna, and Johnson & Johnson, contain instructions for the spike protein but do not actually include the spike protein in the vaccination. The three vaccines allow our cell bodies to make the protein up for itself...
Men’s Health Week: Depression
June 14th through the 20th is Men’s Health Week, which is a great opportunity to heighten awareness for men’s depression. There is a theme in society applicable to most men as they tend to internalize depressive thoughts, not allowing for a proper diagnosis. There are four major reasons men do not reach out for help with their depression: failure to recognize the depression consuming them, downplaying signs and symptoms, reluctance to converse about their feelings with others, and resisting mental health treatment...
Celebrating Pride Month at EMMA International
June 1 started the celebration of Pride Month, which commemorates Lesbian, Gay, Bisexual, and Transgender members. Celebrating Pride Month is also more than celebrating members of the LGBTQIA+, this month is also about recognizing that diversity fuels innovation and collaboration among a variety of industries, including the life sciences...
Growth and Integration of ML/AI in Biotech
The biotechnology and pharmaceutical industries are heavily reliant on collecting, storing, and analyzing data for both R&D as well as production purposes. The large, countless, and rapidly growing sets of data are critical for researchers and scientists to accelerate progress in the medical industry. As our technologies advance and our capacity to store data continue to increase, we must continue to find new ways to efficiently analyze data. Researchers at the European Bioinformatics Institute (EMBL-EBI) have determined that nucleotide and proteomics data is growing at an exponential rate, with the amount of data stored on their servers doubling each year...
Using QFD for Medical Device Development
Quality Function Deployment, or QFD, is a decades-old methodology focused on the voice of the customer. It was initially developed in Japan in the 1960s but was popularized in the US by the automotive industry in the 1980s . QFD is a tool often leveraged by Total Quality Management (TQM), which is a quality principle that customers define quality and subsequently should be prioritized at all stages of the product, both pre-and post-production...
The Appeal and Fears of Digital Health
New digital health technology is coming out every day and is changing the course of the MedTech industry as we know it. Many physicians are making the transition to using these digital health devices and technologies to improve patient care and outcomes. Some of this increase can be attributed to COVID-19 of course as it enabled them to provide care for patients remotely. However, many of these digital health devices and technologies have been around for a bit, so what caused the hesitation in adapting them sooner and what are some of the great perks of this new wave of medical care?
Immune Systems After the COVID-19 Pandemic
Everyone has heard that immune systems weaken when they are sheltered, but is that really the case? As we are now over one year into lockdowns and social distancing, many are becoming concerned that after the pandemic immune systems are going to falter after being isolated for such a long period, and many adults are concerned to resume a “normal” life due to this...
Stability Testing Requirements for Pharmaceuticals
Deciding how and when to conduct stability tests on your new drug can be challenging. Stability tests provide evidence data on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors. It also establishes a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions...
Staying Healthy During COVID-19
EMMA International is continuing to celebrate Women’s Health Week! While there are so many reasons Women’s Health Week is important, one of the best things to come out of this week is the attention it brings and the reminders that we should all consider our health and take steps to ensure a healthy future...
A History of Reproductive Health
Happy National Women’s Health Week! In honor of this week bringing light to important women’s health issues, I wanted to walk through a brief history of innovations that shaped one of the largest facets of women’s health – reproductive health...
Electronic Signatures Under 21CFR§11
Electronic signatures have become increasingly important with the shift to remote work during the pandemic. 21CFR§11 provides regulations for electronic signatures and documentation in FDA-regulated industries to ensure validation and compliance. The regulations require that each electronic signature be unique to an individual and that their identity is authenticated, often with a password or pin. Software used must also maintain traceability of electronic signatures. While there are pre-validated software options, manufacturers are responsible for additionally validating software for their intended use and 21CFR§11 compliance. EMMA International offers assistance with software validation to support compliance with regulatory requirements.
Considerations for Biocompatibility Evaluation
Biocompatibility is one of the most critical performance studies that manufacturers need to perform as part of their product development process. ISO 10993-5 and ISO 10993-10 are FDA-recognized standards for biocompatibility. Whether you perform these studies in-house or send out samples to a third-party lab the protocol for biocompatibility assessment must be conducted in accordance with ISO 10993...
Restoring the Earth for a Healthier Future
Today marks the 52nd anniversary of the birth of the true modern environmental movement, however, you probably know it as Earth Day. Early in the pandemic, many hoped that the lockdowns would help the Earth heal as people began to stay home, stopped commuting, and some factories even had paused production. Unfortunately, as things are beginning to open back up emissions are on the rise again and we need to continue to think about the future consequences...
More from EMMAIntl (20)
Stability Testing of Pharmaceuticals and Supplements
Stability Testing of Pharmaceuticals and Supplements
Stability Testing Requirements for Pharmaceuticals
Stability Testing Requirements for Pharmaceuticals
Recently uploaded
MBC Support Group for Black Women – Insights in Genetic Testing.pdf
Christina Spears, breast cancer genetic counselor at the Ohio State University Comprehensive Cancer Center, joined us for the MBC Support Group for Black Women to discuss the importance of genetic testing in communities of color and answer pressing questions.
LEAD Innovation Launch_WHO Innovation Initiative.pptx
WHO Innovation Initiative. WHO Innovation Initiative. WHO Innovation Initiative. WHO Innovation Initiative.
Let's Talk About It: Breast Cancer (What is Mindset and Does it Really Matter?)
Your mindset is the way you make sense of the world around you. This lens influences the way you think, the way you feel, and how you might behave in certain situations. Let's talk about mindset myths that can get us into trouble and ways to cultivate a mindset to support your cancer survivorship in authentic ways. Let’s Talk About It!
Pediatric Emergency Care for Children | Apollo Hospital
Pediatric Emergency Care for Children | Apollo HospitalApollo 24/7 Adult & Paediatric Emergency Services
At Apollo Hospital, Lucknow, U.P., we provide specialized care for children experiencing dehydration and other symptoms. We also offer NICU & PICU Ambulance Facility Services. Consult our expert today for the best pediatric emergency care.
For More Details:
Map: https://cutt.ly/BwCeflYo
Name: Apollo Hospital
Address: Singar Nagar, LDA Colony, Lucknow, Uttar Pradesh 226012
Phone: 08429021957
Opening Hours: 24X7PrudentRx: A Resource for Patient Education and Engagement
PrudentRx enhances healthcare by educating patients and ensuring effective medication management in a complex, evolving landscape.
R3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
Discover the groundbreaking advancements in stem cell therapy by R3 Stem Cell, offering new hope for women with ovarian failure. This innovative treatment aims to restore ovarian function, improve fertility, and enhance overall well-being, revolutionizing reproductive health for women worldwide.
DRAFT Ventilator Rapid Reference version 2.4.pdf
Ventilator rapid reference for the Zoll Z cvent. Presented for educational purposes only.
Innovative Minds France's Most Impactful Healthcare Leaders.pdf
This edition features a handful of Innovative Minds: France's Most Impactful Healthcare Leaders that are leading us into a better future.
Professional Secrecy: Forensic Medicine Lecture
Professional Secrecy: Forensic Medicine Lecture , Medical jurisprudence
Michigan HealthTech Market Map 2024 with Policy Makers, Academic Innovation C...
Michigan HealthTech Market Map 2024. Includes 7 categories: Policy Makers, Academic Innovation Centers, Digital Health Providers, Healthcare Providers, Payers / Insurance, Device Companies, Life Science Companies, Innovation Accelerators. Developed by the Michigan-Israel Business Accelerator
Comprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdf
The "Comprehensive Rainy Season Advisory: Safety and Preparedness Tips" offers essential guidance for navigating rainy weather conditions. It covers strategies for staying safe during storms, flood prevention measures, and advice on preparing for inclement weather. This advisory aims to ensure individuals are equipped with the knowledge and resources to handle the challenges of the rainy season effectively, emphasizing safety, preparedness, and resilience.
PET CT beginners Guide covers some of the underrepresented topics in PET CT
This lecture briefly covers some of the underrepresented topics in Molecular imaging with cases , such as:
- Primary pleural tumors and pleural metastases.
- Distinguishing between MPM and Talc Pleurodesis.
- Urological tumors.
- The role of FDG PET in NET.
FACIAL NERVE
The facial nerve, also known as cranial nerve VII, is one of the 12 cranial nerves originating from the brain. It's a mixed nerve, meaning it contains both sensory and motor fibres, and it plays a crucial role in controlling various facial muscles, as well as conveying sensory information from the taste buds on the anterior two-thirds of the tongue.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...rightmanforbloodline
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.DR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURY
JOURNAL CLUB - NEEDLE STICK INJURY - TOPIC PRESENTED BY DR SHAMIN
CCSN_June_06 2024_jones. Cancer Rehabpptx
About this webinar: This talk will introduce what cancer rehabilitation is, where it fits into the cancer trajectory, and who can benefit from it. In addition, the current landscape of cancer rehabilitation in Canada will be discussed and the need for advocacy to increase access to this essential component of cancer care.
Can Allopathy and Homeopathy Be Used Together in India.pdf
This article explores the potential for combining allopathy and homeopathy in India, examining the benefits, challenges, and the emerging field of integrative medicine.
Letter to MREC - application to conduct study
Application to conduct study on research title 'Awareness and knowledge of oral cancer and precancer among dental outpatient in Klinik Pergigian Merlimau, Melaka'
Pneumothorax and role of Physiotherapy in it.
This particular slides consist of- what is Pneumothorax,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is a summary of Pneumothorax:
Pneumothorax, also known as a collapsed lung, is a condition that occurs when air leaks into the space between the lung and chest wall. This air buildup puts pressure on the lung, preventing it from expanding fully when you breathe. A pneumothorax can cause a complete or partial collapse of the lung.
DECODING THE RISKS - ALCOHOL, TOBACCO & DRUGS.pdf
Introduction: Substance use education is crucial due to its prevalence and societal impact.
Alcohol Use: Immediate and long-term risks include impaired judgment, health issues, and social consequences.
Tobacco Use: Immediate effects include increased heart rate, while long-term risks encompass cancer and heart disease.
Drug Use: Risks vary depending on the drug type, including health and psychological implications.
Prevention Strategies: Education, healthy coping mechanisms, community support, and policies are vital in preventing substance use.
Harm Reduction Strategies: Safe use practices, medication-assisted treatment, and naloxone availability aim to reduce harm.
Seeking Help for Addiction: Recognizing signs, available treatments, support systems, and resources are essential for recovery.
Personal Stories: Real stories of recovery emphasize hope and resilience.
Interactive Q&A: Engage the audience and encourage discussion.
Conclusion: Recap key points and emphasize the importance of awareness, prevention, and seeking help.
Resources: Provide contact information and links for further support.
Recently uploaded (20)
MBC Support Group for Black Women – Insights in Genetic Testing.pdf
MBC Support Group for Black Women – Insights in Genetic Testing.pdf
LEAD Innovation Launch_WHO Innovation Initiative.pptx
LEAD Innovation Launch_WHO Innovation Initiative.pptx
Let's Talk About It: Breast Cancer (What is Mindset and Does it Really Matter?)
Let's Talk About It: Breast Cancer (What is Mindset and Does it Really Matter?)
Pediatric Emergency Care for Children | Apollo Hospital
Pediatric Emergency Care for Children | Apollo Hospital
PrudentRx: A Resource for Patient Education and Engagement
PrudentRx: A Resource for Patient Education and Engagement
R3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
R3 Stem Cell Therapy: A New Hope for Women with Ovarian Failure
Innovative Minds France's Most Impactful Healthcare Leaders.pdf
Innovative Minds France's Most Impactful Healthcare Leaders.pdf
Michigan HealthTech Market Map 2024 with Policy Makers, Academic Innovation C...
Michigan HealthTech Market Map 2024 with Policy Makers, Academic Innovation C...
Comprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdf
Comprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdf
PET CT beginners Guide covers some of the underrepresented topics in PET CT
PET CT beginners Guide covers some of the underrepresented topics in PET CT
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...
DR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURY
DR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURY
Can Allopathy and Homeopathy Be Used Together in India.pdf
Can Allopathy and Homeopathy Be Used Together in India.pdf
Regulating Regenerative Medicine
- 1. Regulating Regenerative Medicine By: Madison Wheeler In recent years, the field of regenerative medicine has gained significant traction and been pointed to as the future wave of medicine. Regenerative medicine focuses on replacing tissues or organs that have been damaged by disease or other conditions and includes the fields of tissue engineering, cellular therapies, and artificial organs.1 As part of the agency’s commitment to help bring new and innovative treatment options to patients, the FDA regulates regenerative medicine through its Center for Biologics Evaluation and Research (CBER). Through CBER, the FDA supports and expedites the development of human cells, tissues, and cellular/tissue-based products (HCT/P’s) to treat and mitigate diseases. The FDA established 21 CFR 1271 to institute the regulations that regenerative medicine firms must comply with. This part establishes the classic regulations that most firms should be familiar with such as general provisions including the scope and defined terms, procedures for registration and listing, and exceptions. This part also outlines provisions specific to regenerative medicine, such as donor eligibility and Current Good Tissue Practice.2 The regulatory requirements around current good tissue practices govern the methods, facilities, and controls for the manufacture of HCT/P’s. This includes all steps from recovery, donor screening/testing, processing, storage, labeling, packaging, and distribution.3 Since the sector of regenerative medicine is fairly new, the FDA has established 4 final guidance documents that define the regulatory framework for the field. The guidance documents focus on not only helping firms determine if their HCT/P’s are subject to premarket reviews and any exceptions under 21 CFR 1271, but also detail ways the agency is helping bring innovative, safe, and effective HCT/P’s to patients as quickly as possible. An example of an expedited program for regenerative medicine therapies is the RMAT (Regenerative Medicine Advanced Therapy) designation program which, if a product is eligible, includes benefits like expedited FDA review and supplemental interaction with the agency.4 The expanding field of regenerative medicine is a new and exciting addition to public health and one that the FDA is still developing the regulatory framework for. If you are a firm that is interested in exploring regenerative medicine, EMMA International has the expertise to 1 University of Pittsburgh (n.d.) Whatis RegenerativeMedicine? Retrievedon 07/27/2020 from: https://mirm-pitt.net/about-us/what-is- regenerative-medicine/ 2 FDA(n.d.) Title 21 Part 1271 HumanCells, Tissues, and Cellular andTissue-Based Products retrieved on 07/27/2020 from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271 3 FDA(March 2018) Good TissuePractice (CGTP) FinalRuleQuestions and Answers retrievedon 07/27/2020 from: https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/good-tissue-practice-cgtp-final-rule-questions-and- answers#:~:text=Current%20good%20tissue%20practice%20are,%2C%20storage%2C%20labeling%2C%20packaging%2C 4 FDA(February 2019) Expedited Programs for RegenerativeMedicineTherapies for Serious Conditions retrieved on 07/27/2020 from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-regenerative-medicine-therapies-serious- conditions
- 2. Page 2 of 2 help you navigate the regulatory landscape. Contact us at 248-987-4497 or email info@emmainternational.com to get connected to our regulatory experts!