A regulatory strategy is critical to the commercialization of biomedical technologies. In particular, technologies such as new drugs and medical devices have more regulatory needs, and the strategy should be considered simultaneous to a commercialization pathway.
Regulations in clinical research: obligations and responsibilities of investi...TrialJoin
Two of the most important individuals in a clinical trial are investigators and sponsors. However, being such a crucial part of a trial also brings many obligations and responsibilities. Although the sponsor is the one who initiates and finances a trial, the investigator is the person who conducts it. For this reason, most of the obligations and responsibilities fall on the investigator as the person accountable for everything that goes wrong in a trial. Learning these obligations and knowing how to follow them is a crucial practice that will ensure compliance in a clinical trial.
For this reason, we’ve decided to compose this material that will give you a basic outline of all the rules and regulations that investigators and sponsors should follow.
This document summarizes a presentation on personalized medicine and companion diagnostics. It discusses:
1. How the FDA defines companion diagnostics and regulates them along with their corresponding drugs or therapies. This includes different types of biomarkers and validation requirements.
2. Key questions to consider regarding how a technology platform is used for infectious disease or oncology applications and in clinical decision making.
3. Examples of companion diagnostic technologies like tumor vaccines and an FDA approved test for Herceptin.
4. Potential regulatory pathways for companion diagnostic tests including clinical trials and clearance through 510(k) or PMA.
5. Conclusions that statistical analysis differs for co-developed drugs and diagnostics, and positioning a
FDA 2013 Clinical Investigator Training Course: How to Put Together an IDE Ap...MedicReS
This document provides an overview of investigational device exemptions (IDEs) and the process for putting together an IDE application. It discusses what an IDE is, the different types of IDEs, when an IDE is needed, clinical study requirements, and resources for additional information. The main points are: an IDE allows clinical studies of investigational devices and exempts them from some regulations; IDEs can be significant risk or non-significant risk, determining the approval process; and clinical investigations must meet requirements regarding informed consent, monitoring, and reporting.
The document discusses the investigational new drug (IND) application process. It provides an overview of the types of INDs, the roles of sponsors and investigators in clinical trials, and the necessary application materials for FDA review. It also describes the IND review process, including pre-IND meetings, submission requirements, maintenance responsibilities, and ways an IND can conclude. The key message is that safety is the primary focus of the IND process.
The document discusses the key aspects of an Investigational New Drug (IND) application submitted to the FDA to request permission to conduct clinical trials of an unapproved drug. An IND application contains information on the drug's chemistry, manufacturing, pharmacological and toxicological effects, clinical protocol, and investigators brochure. It allows the FDA to ensure the risks to human subjects are reasonable. The FDA reviews INDs within 30 days to determine if a clinical hold is needed before trials can begin. Annual reports updating trial progress are also required.
The document provides information about an upcoming presentation on Good Clinical Practice (GCP). It includes:
1) Details about the presenter including his background and experience in clinical research.
2) The learning objectives of the presentation which are to define GCP, differentiate GCP requirements from recommendations, and identify circumstances where industry best practices go beyond FDA requirements.
3) An introduction stating the presentation was developed to correct common myths and errors heard about GCP throughout the presenter's career.
Regulations in clinical research: obligations and responsibilities of investi...TrialJoin
Two of the most important individuals in a clinical trial are investigators and sponsors. However, being such a crucial part of a trial also brings many obligations and responsibilities. Although the sponsor is the one who initiates and finances a trial, the investigator is the person who conducts it. For this reason, most of the obligations and responsibilities fall on the investigator as the person accountable for everything that goes wrong in a trial. Learning these obligations and knowing how to follow them is a crucial practice that will ensure compliance in a clinical trial.
For this reason, we’ve decided to compose this material that will give you a basic outline of all the rules and regulations that investigators and sponsors should follow.
This document summarizes a presentation on personalized medicine and companion diagnostics. It discusses:
1. How the FDA defines companion diagnostics and regulates them along with their corresponding drugs or therapies. This includes different types of biomarkers and validation requirements.
2. Key questions to consider regarding how a technology platform is used for infectious disease or oncology applications and in clinical decision making.
3. Examples of companion diagnostic technologies like tumor vaccines and an FDA approved test for Herceptin.
4. Potential regulatory pathways for companion diagnostic tests including clinical trials and clearance through 510(k) or PMA.
5. Conclusions that statistical analysis differs for co-developed drugs and diagnostics, and positioning a
FDA 2013 Clinical Investigator Training Course: How to Put Together an IDE Ap...MedicReS
This document provides an overview of investigational device exemptions (IDEs) and the process for putting together an IDE application. It discusses what an IDE is, the different types of IDEs, when an IDE is needed, clinical study requirements, and resources for additional information. The main points are: an IDE allows clinical studies of investigational devices and exempts them from some regulations; IDEs can be significant risk or non-significant risk, determining the approval process; and clinical investigations must meet requirements regarding informed consent, monitoring, and reporting.
The document discusses the investigational new drug (IND) application process. It provides an overview of the types of INDs, the roles of sponsors and investigators in clinical trials, and the necessary application materials for FDA review. It also describes the IND review process, including pre-IND meetings, submission requirements, maintenance responsibilities, and ways an IND can conclude. The key message is that safety is the primary focus of the IND process.
The document discusses the key aspects of an Investigational New Drug (IND) application submitted to the FDA to request permission to conduct clinical trials of an unapproved drug. An IND application contains information on the drug's chemistry, manufacturing, pharmacological and toxicological effects, clinical protocol, and investigators brochure. It allows the FDA to ensure the risks to human subjects are reasonable. The FDA reviews INDs within 30 days to determine if a clinical hold is needed before trials can begin. Annual reports updating trial progress are also required.
The document provides information about an upcoming presentation on Good Clinical Practice (GCP). It includes:
1) Details about the presenter including his background and experience in clinical research.
2) The learning objectives of the presentation which are to define GCP, differentiate GCP requirements from recommendations, and identify circumstances where industry best practices go beyond FDA requirements.
3) An introduction stating the presentation was developed to correct common myths and errors heard about GCP throughout the presenter's career.
FDA Enforcement: What Every Clinical Director Should KnowMichael Swit
Half day tutorial presentation on key compliance concerns for those involved in clinical studies, with an emphasis on the key issues FDA examines and also a review of FDA's enforcement powers, ranging from warning letters to criminal prosecutions.
An IND application is submitted to the FDA to request permission to conduct clinical trials on an investigational new drug. It contains preclinical animal and toxicity data, manufacturing information, and clinical trial protocols and investigator information. The FDA reviews the IND over 30 days to ensure the protection of human subjects and that the investigational plan allows for evaluation of safety and effectiveness. Clinical trials cannot begin until the IND is approved or the 30-day review period has ended without FDA objection. Sponsors must submit annual reports updating the FDA on the progress of investigations under the IND.
This document outlines the regulations for investigational new drugs as described in Part 312 of Title 21 of the Code of Federal Regulations. It discusses the requirements for investigational new drug applications (INDs), including the content that must be submitted in an IND. Key points covered include the phases of clinical investigation for a new drug, safety reporting requirements for INDs, protocols for amending an IND, and the conditions under which FDA can place a clinical hold, terminate an IND, or change a drug's status. The purpose is to ensure new drugs are properly evaluated for safety and effectiveness before being approved for marketing.
Investigational new drug application must be submitted after discovering a new drug and before beginning of clinical trials. Here given a brief note on the topic.The topics included are types of IND, criteria for application, Information in IND application, resources for IND application, laws.regulations, policies and procedures, IND forms and instructions, IND content requirements and review of IND
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
INDA (INVESTIGATIONAL NEW DRUG APPLICATIONS)AshishDhiman53
This document provides an overview of Investigational New Drug Applications (INDAs), which are required for clinical trials of unapproved drugs in the US. It defines INDAs and explains why they are needed, the types of INDAs, contents of an INDA submission, resources for preparing INDAs, the INDA review process, and the phases of investigation that can occur after an successful INDA. The goal of an INDA is to obtain permission to ship an experimental drug and begin human clinical trials before the drug is approved for marketing.
This document discusses the requirements and process for submitting an Investigational New Drug (IND) application to the FDA. An IND allows companies to conduct clinical trials of new drug products and provides the FDA data to assess risks to trial subjects. Key parts of an IND include an introductory statement describing the drug, a clinical trial protocol, safety data from animal and previous human studies, and an Investigator's Brochure with summary data for clinical investigators. Companies can schedule a pre-IND meeting with the FDA to discuss requirements for the IND submission and initial clinical trial design.
Guidelines on the collection verification and submission of reports on advers...Serkan Kaçar
Guidelines on the collection verification and submission of reports on adverse events reactions arising during clinical trials, , published by Turkish Medicine and Medical Device Agency
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.
- The document compares the FDA regulations for clinical trials to the International Conference on Harmonization's (ICH) Good Clinical Practice (GCP) guidelines.
- There are some differences between the two, such as ICH requiring more documentation of trial procedures and delegation of duties, while FDA regulations are less specific.
- Overall ICH GCP guidelines facilitate international harmonization and acceptance of clinical trial data between the US, EU, and Japan. Compliance with ICH GCP helps assure rights and safety of trial subjects.
This document discusses Investigational New Drug (IND) applications and New Drug Applications (NDA). It provides details on the process for approval of new drugs in the US and India. Some key points include:
- An IND must be filed with the FDA before beginning clinical trials of an investigational new drug in humans. It contains information on pre-clinical studies, manufacturing, and clinical protocols.
- In India, a similar process involves submitting an application on Form 44 to the Central Drugs Standard Control Organization along with required documents and fees.
- An NDA is submitted to formally request approval to market a new drug after Phase III trials. It contains extensive data from non-clinical and clinical studies in a
Conducting Studies to the International Gold Standard: Going Beyond What the ...Paul Below
The document discusses the differences between the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (GCP) and the U.S. Food and Drug Administration (FDA) regulations for clinical trials. The ICH guidelines aim to harmonize standards across countries in order to streamline drug development. Key differences highlighted in the document include additional informed consent requirements, documentation standards, and record retention timelines under the ICH guidelines compared to FDA regulations. Adhering to the international gold standard of the ICH GCP guidelines can facilitate global drug development and approval processes.
FDA 2013 Clinical Investigator Training Course: Good Clinical Practice MedicReS
This document summarizes a presentation on good clinical practice and investigator responsibilities. It discusses topics like investigator responsibilities under FDA regulations, financial disclosure requirements for clinical investigators, expanded access to investigational drugs and devices, and charging for investigational products. It provides guidance on appropriate delegation of tasks, training of study staff, supervision responsibilities, and subject protections for investigators. It also reviews the FDA's regulations and guidance on financial disclosure, expanded access, and charging for investigational medical products.
Investigational new drug application newAakrati Gupta
The document provides an overview of Investigational New Drug (IND) applications submitted to the FDA when conducting clinical trials of new drug products. An IND is required before any clinical testing of an unapproved drug can begin and allows the sponsor to ship the drug across state lines for research purposes. The document outlines the content and format of an IND application, including a cover sheet, introductory statement, investigational plan, clinical protocol, chemistry/manufacturing data, and previous human experience. It also discusses FDA review of INDs and annual reporting requirements.
A Brief Guide to the FDA Drug Approval ProcessPerficient
The FDA drug approval process consists of 4 phases: pre-clinical testing on animals, clinical trials with humans (phases I-III), submission of a New Drug Application including all data, and post-marketing safety monitoring if approved. Phase I involves initial safety testing on 20-80 people. Phase II expands to hundreds of patients to preliminarily assess effectiveness. Phase III involves thousands of patients to further evaluate safety and effectiveness in various populations. If approved after review of the application and manufacturing facilities, the drug is monitored post-market for adverse events.
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
An Investigational New Drug (IND) application allows a sponsor to legally test an unapproved or investigational drug in clinical trials. The sponsor must provide preclinical data on pharmacology, toxicology and manufacturing to show the drug is reasonably safe for initial human testing. After submitting an IND, clinical trials can begin if FDA does not disapprove the application within 30 days. The IND application process and clinical trials are regulated to ensure data quality and subject safety.
The difference between practice and research 111607Lanka Praneeth
The document discusses the key differences between clinical practice and clinical research. Clinical research must be conducted according to an approved protocol and involves more oversight, documentation and risk to subjects. It outlines sponsor and investigator responsibilities, good clinical practice standards, and FDA expectations for clinical trial design, conduct and oversight. Clinical trials aim to generate generalizable knowledge, while practice focuses on individual patient treatment.
FDA Enforcement: What Every Clinical Director Should KnowMichael Swit
Half day tutorial presentation on key compliance concerns for those involved in clinical studies, with an emphasis on the key issues FDA examines and also a review of FDA's enforcement powers, ranging from warning letters to criminal prosecutions.
An IND application is submitted to the FDA to request permission to conduct clinical trials on an investigational new drug. It contains preclinical animal and toxicity data, manufacturing information, and clinical trial protocols and investigator information. The FDA reviews the IND over 30 days to ensure the protection of human subjects and that the investigational plan allows for evaluation of safety and effectiveness. Clinical trials cannot begin until the IND is approved or the 30-day review period has ended without FDA objection. Sponsors must submit annual reports updating the FDA on the progress of investigations under the IND.
This document outlines the regulations for investigational new drugs as described in Part 312 of Title 21 of the Code of Federal Regulations. It discusses the requirements for investigational new drug applications (INDs), including the content that must be submitted in an IND. Key points covered include the phases of clinical investigation for a new drug, safety reporting requirements for INDs, protocols for amending an IND, and the conditions under which FDA can place a clinical hold, terminate an IND, or change a drug's status. The purpose is to ensure new drugs are properly evaluated for safety and effectiveness before being approved for marketing.
Investigational new drug application must be submitted after discovering a new drug and before beginning of clinical trials. Here given a brief note on the topic.The topics included are types of IND, criteria for application, Information in IND application, resources for IND application, laws.regulations, policies and procedures, IND forms and instructions, IND content requirements and review of IND
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
INDA (INVESTIGATIONAL NEW DRUG APPLICATIONS)AshishDhiman53
This document provides an overview of Investigational New Drug Applications (INDAs), which are required for clinical trials of unapproved drugs in the US. It defines INDAs and explains why they are needed, the types of INDAs, contents of an INDA submission, resources for preparing INDAs, the INDA review process, and the phases of investigation that can occur after an successful INDA. The goal of an INDA is to obtain permission to ship an experimental drug and begin human clinical trials before the drug is approved for marketing.
This document discusses the requirements and process for submitting an Investigational New Drug (IND) application to the FDA. An IND allows companies to conduct clinical trials of new drug products and provides the FDA data to assess risks to trial subjects. Key parts of an IND include an introductory statement describing the drug, a clinical trial protocol, safety data from animal and previous human studies, and an Investigator's Brochure with summary data for clinical investigators. Companies can schedule a pre-IND meeting with the FDA to discuss requirements for the IND submission and initial clinical trial design.
Guidelines on the collection verification and submission of reports on advers...Serkan Kaçar
Guidelines on the collection verification and submission of reports on adverse events reactions arising during clinical trials, , published by Turkish Medicine and Medical Device Agency
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.
- The document compares the FDA regulations for clinical trials to the International Conference on Harmonization's (ICH) Good Clinical Practice (GCP) guidelines.
- There are some differences between the two, such as ICH requiring more documentation of trial procedures and delegation of duties, while FDA regulations are less specific.
- Overall ICH GCP guidelines facilitate international harmonization and acceptance of clinical trial data between the US, EU, and Japan. Compliance with ICH GCP helps assure rights and safety of trial subjects.
This document discusses Investigational New Drug (IND) applications and New Drug Applications (NDA). It provides details on the process for approval of new drugs in the US and India. Some key points include:
- An IND must be filed with the FDA before beginning clinical trials of an investigational new drug in humans. It contains information on pre-clinical studies, manufacturing, and clinical protocols.
- In India, a similar process involves submitting an application on Form 44 to the Central Drugs Standard Control Organization along with required documents and fees.
- An NDA is submitted to formally request approval to market a new drug after Phase III trials. It contains extensive data from non-clinical and clinical studies in a
Conducting Studies to the International Gold Standard: Going Beyond What the ...Paul Below
The document discusses the differences between the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (GCP) and the U.S. Food and Drug Administration (FDA) regulations for clinical trials. The ICH guidelines aim to harmonize standards across countries in order to streamline drug development. Key differences highlighted in the document include additional informed consent requirements, documentation standards, and record retention timelines under the ICH guidelines compared to FDA regulations. Adhering to the international gold standard of the ICH GCP guidelines can facilitate global drug development and approval processes.
FDA 2013 Clinical Investigator Training Course: Good Clinical Practice MedicReS
This document summarizes a presentation on good clinical practice and investigator responsibilities. It discusses topics like investigator responsibilities under FDA regulations, financial disclosure requirements for clinical investigators, expanded access to investigational drugs and devices, and charging for investigational products. It provides guidance on appropriate delegation of tasks, training of study staff, supervision responsibilities, and subject protections for investigators. It also reviews the FDA's regulations and guidance on financial disclosure, expanded access, and charging for investigational medical products.
Investigational new drug application newAakrati Gupta
The document provides an overview of Investigational New Drug (IND) applications submitted to the FDA when conducting clinical trials of new drug products. An IND is required before any clinical testing of an unapproved drug can begin and allows the sponsor to ship the drug across state lines for research purposes. The document outlines the content and format of an IND application, including a cover sheet, introductory statement, investigational plan, clinical protocol, chemistry/manufacturing data, and previous human experience. It also discusses FDA review of INDs and annual reporting requirements.
A Brief Guide to the FDA Drug Approval ProcessPerficient
The FDA drug approval process consists of 4 phases: pre-clinical testing on animals, clinical trials with humans (phases I-III), submission of a New Drug Application including all data, and post-marketing safety monitoring if approved. Phase I involves initial safety testing on 20-80 people. Phase II expands to hundreds of patients to preliminarily assess effectiveness. Phase III involves thousands of patients to further evaluate safety and effectiveness in various populations. If approved after review of the application and manufacturing facilities, the drug is monitored post-market for adverse events.
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
An Investigational New Drug (IND) application allows a sponsor to legally test an unapproved or investigational drug in clinical trials. The sponsor must provide preclinical data on pharmacology, toxicology and manufacturing to show the drug is reasonably safe for initial human testing. After submitting an IND, clinical trials can begin if FDA does not disapprove the application within 30 days. The IND application process and clinical trials are regulated to ensure data quality and subject safety.
The difference between practice and research 111607Lanka Praneeth
The document discusses the key differences between clinical practice and clinical research. Clinical research must be conducted according to an approved protocol and involves more oversight, documentation and risk to subjects. It outlines sponsor and investigator responsibilities, good clinical practice standards, and FDA expectations for clinical trial design, conduct and oversight. Clinical trials aim to generate generalizable knowledge, while practice focuses on individual patient treatment.
The document provides an overview of the Investigational New Drug Application (IND) and New Drug Application (NDA) processes required by the FDA to develop and approve new drugs. It describes how developing a new drug takes 15 years and over $900 million on average. The IND allows testing of new drugs in humans and provides safety data, while the NDA provides all clinical trial data for the FDA to determine if the drug is safe and effective for approval. Both the IND and NDA are lengthy applications that require extensive non-clinical and clinical data to gain FDA approval to market a new prescription drug.
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...Audumbar Mali
The document provides information on the regulatory approval process for drugs. It discusses the various stages of approval including investigational new drug applications (IND), new drug applications (NDA), and abbreviated new drug applications (ANDA).
The stages include pre-clinical testing, clinical trials through multiple phases, and regulatory review and approval. An IND must be approved by the FDA before clinical trials in humans can begin. If clinical trials are successful, manufacturers can file an NDA to request approval to market the drug. For generic drugs, an ANDA can be filed to demonstrate bioequivalence to an existing approved drug, without needing to re-conduct clinical trials. The approval process is complex and lengthy, usually taking 10-
Ind (investigational new drug application) and ndaswati2084
The document provides an overview of the Investigational New Drug Application (IND) and New Drug Application (NDA) processes for bringing new drugs to market. It describes how an IND must be submitted to the FDA to test an experimental drug in humans, and outlines the types of INDs, content requirements, and review process. An NDA contains extensive clinical trial data and is required for FDA approval to commercially market a new drug. The lengthy and costly process from initial research to marketing approval averages 15 years and $900 million per new drug.
An Investigational New Drug (IND) application allows a sponsor to lawfully use an investigational drug for clinical investigation purposes. It provides information on preclinical testing, clinical protocols, manufacturing, and investigator qualifications to ensure subject safety. An IND is required for clinical studies intended to support a new indication, change in dosage/administration, or different patient population. It exempts the sponsor from prohibitions on shipping unapproved drugs and facilitates three phases of clinical trials to evaluate safety and efficacy.
The document discusses Investigational New Drug (IND) applications, which are submitted to the FDA to obtain approval to begin human clinical trials of an experimental drug. An IND application includes preclinical animal data, clinical trial protocols, and information about manufacturing. The FDA has 30 days to review an IND for safety before trials may begin. Clinical holds may be placed on applications that pose unreasonable risks or are missing required information. Notifications are provided to sponsors regarding review outcomes and any deficiencies that must be addressed.
PART 1 _ Documentation of drug trials and regulatory filings (1).pptxDilsarGohil1
The document discusses documentation required for Investigational New Drug (IND) applications submitted to regulatory authorities like the FDA. An IND application is required to get approval to start clinical trials of an investigational drug. It must include preclinical animal study and toxicity data, manufacturing information, clinical trial protocols, and prior human research data. If approved, the IND allows the sponsor to begin clinical trials to investigate safety and efficacy of the new drug in humans. The clinical trials are divided into four phases with increasing number of participants.
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
IND (Investigational New Drug) industrial perspectiveAYESHA NAZEER
Describing the Industry's/sponsor's/drug manufacturers' perspective of the Investigational New Drug Application (IND) program based on the survey conducted by the Office Of Inspector General (OIG).
This document summarizes key aspects of non-clinical drug development. It discusses how non-clinical studies are performed in silico, in vitro, and in vivo to assess safety, efficacy, pharmacokinetics, and manufacturing viability before human clinical trials. It also describes the Investigational New Drug application process which is required to begin clinical trials in humans, and provides an overview of the New Drug Application submitted for marketing approval. The document concludes by outlining the contents of an Investigational Medicinal Products Dossier which forms the basis for approval of multinational clinical trials in the European Union.
An Investigational New Drug (IND) application is required for clinical trials of any new drug or biological product. The IND application contains information on preclinical studies, manufacturing, protocols, investigator information and more. It allows the FDA to monitor clinical trials and place a hold if needed. Clinical trials are divided into Phases I-III to test safety, efficacy and dosing. The IND holder, sponsor and investigators all have responsibilities to protect subjects and ensure proper conduct of the clinical trials. Amendments are made to the IND as more information becomes available.
The document discusses the regulatory process for investigational new drugs (INDs) and new drug applications (NDAs) in the United States. It provides details on the types of INDs (investigator, emergency use, treatment), categories (commercial, research), required contents of an IND application, and FDA's Pre-IND consultation program. It also summarizes the purpose and required contents of an NDA to obtain approval to market a new drug in the US. Laws, regulations, guidance documents, and procedures that FDA follows in regulating drugs are also referenced.
Overview regulatory environment in usa,europe,indiashabana parveen
The document summarizes the process for clinical research and drug approval by the FDA. It describes the multi-step process including pre-clinical research in animals, Phase 1-3 clinical trials in humans to test safety and efficacy, and the submission of a New Drug Application. The FDA rigorously reviews data at each stage before approving progression to the next stage to ensure safety. The overall process aims to establish that new drugs are safe and effective for use by the American public.
The document provides information on Investigational New Drug (IND) enabling studies and the IND application process. Some key points:
- An IND application is required to ship an experimental drug across state lines for clinical trials before marketing approval. The FDA reviews the IND for safety.
- An IND application contains information on animal studies, chemistry/manufacturing, and clinical trial protocols. It must demonstrate the drug is reasonably safe for initial human testing.
- An IND application must follow specific guidelines, including summaries of pharmacology/toxicology studies, chemistry/manufacturing details, clinical protocols, and responsibilities of investigators and sponsors. It allows the drug to enter Phase I clinical trials upon
This document discusses Investigational New Drug Applications (INDs), which are required for clinical studies involving investigational drugs. There are three main types of INDs: investigator INDs submitted by physicians, emergency use INDs for emergency situations, and treatment INDs for drugs showing promise for serious conditions. The FDA reviews INDs to ensure proposed clinical trials will not expose subjects to unnecessary risks, investigators are qualified, and informed consent and institutional review board oversight are in place. IND applications must provide preclinical and manufacturing data as well as detailed protocols for proposed clinical studies. The FDA's objectives in reviewing INDs are to ensure safety, rights of subjects, and adequate scientific evaluation of a drug's effectiveness.
The document discusses regulatory requirements for non-clinical drug development, including guidelines from the European Medicines Agency. It describes the types of non-clinical studies done in silico, in vitro, and in vivo to determine efficacy, safety, delivery methods, and manufacturing viability before clinical trials. Key submissions to regulators include the Investigational New Drug Application, New Drug Application, and Abbreviated New Drug Application.
Similar to The Rough Waters of the Regulatory Environment (20)
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
9
Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
A Visual Guide to 1 Samuel | A Tale of Two HeartsSteve Thomason
These slides walk through the story of 1 Samuel. Samuel is the last judge of Israel. The people reject God and want a king. Saul is anointed as the first king, but he is not a good king. David, the shepherd boy is anointed and Saul is envious of him. David shows honor while Saul continues to self destruct.
Walmart Business+ and Spark Good for Nonprofits.pdfTechSoup
"Learn about all the ways Walmart supports nonprofit organizations.
You will hear from Liz Willett, the Head of Nonprofits, and hear about what Walmart is doing to help nonprofits, including Walmart Business and Spark Good. Walmart Business+ is a new offer for nonprofits that offers discounts and also streamlines nonprofits order and expense tracking, saving time and money.
The webinar may also give some examples on how nonprofits can best leverage Walmart Business+.
The event will cover the following::
Walmart Business + (https://business.walmart.com/plus) is a new shopping experience for nonprofits, schools, and local business customers that connects an exclusive online shopping experience to stores. Benefits include free delivery and shipping, a 'Spend Analytics” feature, special discounts, deals and tax-exempt shopping.
Special TechSoup offer for a free 180 days membership, and up to $150 in discounts on eligible orders.
Spark Good (walmart.com/sparkgood) is a charitable platform that enables nonprofits to receive donations directly from customers and associates.
Answers about how you can do more with Walmart!"
Level 3 NCEA - NZ: A Nation In the Making 1872 - 1900 SML.pptHenry Hollis
The History of NZ 1870-1900.
Making of a Nation.
From the NZ Wars to Liberals,
Richard Seddon, George Grey,
Social Laboratory, New Zealand,
Confiscations, Kotahitanga, Kingitanga, Parliament, Suffrage, Repudiation, Economic Change, Agriculture, Gold Mining, Timber, Flax, Sheep, Dairying,
7. AGENDA
1.DEFINITIONS AND APPLICABLE REGULATIONS
2. INVESTIGATIONAL NEW DRUG (IND) PROCESS
3. INVESTIGATONAL DEVICE EXEMPTION (IDE) PROCESS
4. RESOURCES AVAILABLE
5. CASE EXAMPLES
8. Definitions Related to Drugs
Investigational Drug is a new drug or biologic used in a clinical
investigation
Drug: articles used to treat, mitigate, cure, diagnose, or prevent a
disease in man or other animals; and articles intended to affect the
structure or any function of the body
IND application: An Investigational New Drug (IND) Application is a
request for authorization to administer an investigational drug or biologic
to humans or to administer a marketed (approved) drug for a new
indication, dosage and/or patient population. An IND contains
documentation submitted to the Food and Drug Administration (FDA) to
allow for the conduct of a clinical study using an investigational drug
9. Definitions related to Devices
Investigational Device: An investigational device is a medical device that is the
subject of a clinical study designed to evaluate the effectiveness and/or safety of
the device.
Device: an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent or other similar or related article including any component part or accessory,
which is recognized in the National Formulary, or U.S. Pharmacopoeia, or any
supplement to them, intended for use in the diagnosis of disease or other
conditions or in the cure, mitigation, treatment or prevention of a disease in
man or other animals; and articles intended to affect the structure or any
function of the body (not through chemical means)
IDE application: An Investigational Device Exemption (IDE) contains documentation
submitted to the FDA to allow for the conduct of a clinical study using a significant
risk device that is new or not approved for the proposed indication. An IDE covers
the procedures for the conduct of clinical studies with medical devices including
application, responsibilities of sponsors and investigators, labeling, records, and
reports.
10. Definitions (continued)
• Sponsor is an individual, company, academic institution, or other
organization that takes responsibility for and initiates a clinical investigation.
The sponsor is not the “funding organization” by FDA definitions.
• Investigator is an individual under whose immediate direction a
drug/device is administered or dispensed.
• Sponsor-Investigator is an individual who both initiates and conducts an
investigation. The requirements/responsibilities under this part include both
those applicable to an investigator and a sponsor. Sponsor-Investigators
must also conclude or close investigations.
12. Regulations
APPLICABLE REGULATIONS
The Federal Food, Drug, and Cosmetic Act (FD&C Act)
gives the FDA authority to regulate drugs and devices
Drugs/Biologics/Medical Devices
Code of Federal Regulations (CFR)
14. Regulations
21 CFR §11 Electronic Records; Electronic Signatures
21 CFR §50 FDA (21 CFR) Protection of Human Subjects
21 CFR §54 Financial Disclosure by Clinical Investigators
21 CFR §56 Institutional Review Boards
21 CFR §58 Good Laboratory Practices
21 CFR §211, § 810 Good Manufacturing Practices
21 CFR § 820 Quality System Regulation
21 CFR §1271 Good Tissue Practices
15. If a Federally Funded Study…
Regulations
45 CFR Part 46 (DHHS) Protection of Human Subjects
16. AGENDA
1. DEFINITIONS AND APPLICABLE REGULATIONS
2. INVESTIGATIONAL NEW DRUG (IND) PROCESS
3. INVESTIGATONAL DEVICE EXEMPTION (IDE) PROCESS
4. RESOURCES AVAILABLE
5. CASE EXAMPLES
17. IND Applicability
IND means an investigational new drug application;
synonymous with Notice of Claimed Investigational Exemption
for a New Drug;
Investigational new drug means a new drug or biological drug
that is used in a clinical investigation. It also includes a
biological product that is used in vitro for diagnostic purposes.
NOTE: IND application refers to route and dose as well as
new indication or new population!
18. When is an IND Needed?
Sponsor/Investigator intends to conduct a clinical study with an
investigational drug
Sponsor/Investigator intends to conduct a study with an
approved drug, but…
in a new indication/population
dosage form OR
dosage range that is not covered in the current package
insert (off label)
19. When is an IND NOT Needed?
IND Exemption Criteria
• Lawfully marketed in the US and :
– Not intended to support a new indication;
– Not intended to support a change in advertising;
– Does not involve a factor that increases risk of use;
– Conducted in compliance with IRB and Informed Consent
requirements;
– Complies with the requirements for promotion and charging of
investigational drugs.
23. What Information is Needed to Submit an IND?
Final Protocol
(If oncology trial, the protocol should have PRC approval before submitting to the FDA)
Final Informed Consent Document (and other associated
documents)
Draft Case Report Forms
PI CV (signed and current)
Investigator’s Brochure (for multi-center study)
Labeling information (for approved drug)
Letter of Authorization (LOA) to cross-reference a company’s
product (for off-label use)
Relevant reference articles
24. Content Requirements per 21 CFR 312.23
Cover Sheet
Table of Contents
Introductory statement and General Investigational Plan
Investigator Brochure (IB)
Study Protocol and Informed Consent
Chemistry, Manufacture, and Control Information (via LOA)
Pharmacology and Toxicology Information (via LOA)
Previous Human Experience (via LOA)
Additional Information (draft CRFs, hard-copy reference articles)
25. Responsibilities
FDA Submissions - Responsibilities To FDA for an IND (312.32-IND safety reports)
Submission Timing
Amendment - New protocol After IRB approval
Amendment - Changed protocol At time of change
Amendment - New investigator Within 30 days of being added
Amendment - Information At time of occurrence
IND safety report (Serious and unexpected
suspected adverse reaction, findings from
other studies, findings from animal or in vitro
testing, increased rate of occurrence of serious
suspected adverse reactions)
Within 15 calendar days of receiving notification
IND safety report (Unexpected fatal or life-threatening
suspected adverse reaction)
Within 7 calendar days of receiving notification
Annual report Within 60 days of anniversary of IND
Withdrawal of IND At time of withdrawal
Discontinuation of investigation Within 5 working days of discontinuance
Financial disclosure report At time of change
26. AGENDA
1. DEFINITIONS AND APPLICABLE REGULATIONS
2. INVESTIGATIONAL NEW DRUG (IND) PROCESS
3. INVESTIGATONAL DEVICE EXEMPTION (IDE) PROCESS
4. RESOURCES AVAILABLE
5. CASE EXAMPLES
27. Regulatory Controls
P
a
t
i
e
n
t
R
i
s
k
Class I
General
Controls
Class II
General &
Special
Controls
510(k)
IDE (??)
Class III
PMA
IDE
Required
MEDICAL DEVICES
FDA RISK BASED CLASSIFICATION SCHEME
29. Who Decides Whether a Device is SR or NSR?
Sponsor/Investigator
Make the initial risk determination
Presents the IRB with information
Description of the device
Reports of prior investigations
Proposed investigational plan
Subject selection criteria
IRBs
Required to determine whether the device study involves a SR or NSR device. For
an investigational device that is considered to be non-significant risk, the IRB can
approve the “IDE”.
FDA
Available to help
Final arbiter
31. Significant Risk device is an investigational device that:
(1) is intended as an implant and presents a potential for serious risk to
the health, safety, or welfare of a subject;
(2) is for use in supporting or sustaining human life and represents a
potential for serious risk to the health, safety, or welfare of a subject;
(3) is for a use of substantial importance in diagnosing, curing, mitigating,
or treating disease or otherwise preventing impairment of human
health and presents a potential for serious risk to the health, safety, or
welfare of a subject; or
(4) otherwise presents a potential for serious risk to a subject.
32. Non-significant Risk Devices
Non-significant risk devices are devices that do not pose a potential for
serious risk to the human subjects.
A NSR device study requires only IRB approval prior to initiation of a
clinical study. Sponsors of studies involving NSR devices are not required
to submit an IDE application to FDA for approval. Submissions for NSR
device investigations are made directly to the IRB of each participating
institution.
If the IRB disagrees and determines that the device poses a SR, the
sponsor must report this finding to FDA within five working days
[§812.150(b)(9)].
FDA considers an investigation of a NSR device to have an approved IDE
when IRB concurs with the NSR determination and approves the study.
33. IDE Exempt if:
Used in accordance with indications/labeling
Non-invasive diagnostic
Consumer preference testing
Solely for veterinary use
Research on or with lab animals
34. What are the Requirements for NSR Device Studies?
• Abbreviated requirements per 21CFR 812.2(b)
Labeling
IRB approval
informed consent
monitoring
record keeping
reports
prohibition against promotion.
• NSR studies are considered to have an approved IDE therefore no IDE to
FDA
• Sponsors and IRBs do not have to advise FDA of NSR device studies
• IRBs must make a SR or NSR determination for every NSR study (21
CFR 812.66)
35. Requirements for an IDE Application (for SR devices)
Name and address of the sponsor
Complete report of prior investigations of the device
Investigational Plan, including monitoring procedures
Description of the methods, facilities, and controls used for the manufacture,
processing, packing, storage of the device
Investigational agreement
Investigator names, institutions, and CVs
IRB information
Amount being charged for the device and explanation why the sale does not
constitute commercialization
Labels
Informed Consent
Additional information
36. Responsibilities
FDA Submissions - Responsibilities To FDA for an IDE (812.150)
Submission Timing
Supplement- New protocol After IRB approval
Supplement- Changed protocol At time of change
Supplement - New investigator Within 30 days of being added
Supplement - Information At time of occurrence
Unanticipated Adverse Device Effects Within 10 working days of receiving notification
Recalls and Device Disposition Within 30 days
Progress/Annual report At regular intervals (at least yearly)
Withdrawal of IRB or FDA approval Within 5 working days of receipt of notice
Completion or Termination of investigation
Within 30 days
– Final Report
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/In
vestigationalDeviceExemptionIDE/ucm046717.htm
37. AGENDA
1. DEFINITIONS AND APPLICABLE REGULATIONS
2. INVESTIGATIONAL NEW DRUG (IND) PROCESS
3. INVESTIGATONAL DEVICE EXEMPTION (IDE) PROCESS
4.RESOURCES AVAILABLE
5. CASE EXAMPLES
38. MIAP is here to Help!
Photo by Rebel Sessions/Nic Bothma
39. Resources
MICHR IND/IDE Investigator Assistance
Program (MIAP) Provides Comprehensive:
Regulatory Expertise…
Regulatory Support…
Regulatory Education…
…To Investigators and their Team Involved
In FDA Regulated Research.
40. SERVICES OVERVIEW
Agent/Device
development/regulatory strategy
consultation
IND/IDE consultation including
determination of need for IND or
IDE
Pre-IND/IDE FDA meeting
requests and support
Protocol/Informed Consent
review
IND/IDE application preparation
and submission to FDA
Services
Clinical hold/conditional approval
response preparation/submission
Communication with the FDA, IRB
and other regulatory bodies
IND/IDE “maintenance” support
– Safety report submissions
– Protocol amendments
– Annual reports
– Investigator Amendments
– Informational Amendments
41. Challenges and Solutions for Early
Sponsor-Investigator Support
Seymour, Wright, Reisdorph, Moore, Weatherwax; Experimental Biology 2012
42. Challenges
Gap Analysis
Sponsor-investigators often provide clinical protocols and study-related
materials with information gaps that affect an IND or IDE submission.
Solutions
• Review the medical literature
• Review FDA Guidance documents
• Research similar products and their regulatory paths
• Perform due diligence on the nonclinical and clinical studies/data that
support the IND or IDE
Challenges/Solutions
43. Challenges
Challenges/Solutions
Regulatory Writing
FDA submissions require a unique format and clear writing with
attention to principles of Good Clinical Practice. This effort begins with a
well-written clinical study protocol.
Solutions
• Transform research proposals into clinical protocols
• Transform clinical protocols into IND/IDE submissions
• Assist with informed consent documents and case report forms
• Assist with IRB submissions
44. Challenges
Challenges/Solutions
Industry Interaction
Sponsor-investigators have limited experience interacting with industry
regulatory professionals. Industry may not cooperate with individual
sponsor-investigators or place undue burden upon them causing
unnecessary project delays.
Solutions
• Assist with obtaining Letters of Authorization, Right of Reference, and
Investigator Brochures
• Assist with industry cooperation and communication
• Assist with industry-requested safety reporting
45. Challenges
Challenges/Solutions
FDA Interaction
Sponsor-investigators have limited experience interacting with FDA,
limited knowledge of FDA requirements, and limited resources to
address these gaps.
Solutions
• Conduct IND/IDE submissions and maintenance
• Prepare and submit FDA meeting packets
• Attend FDA meetings
• Respond to FDA inquiries and requests
• Assist with study/site monitoring and audit preparation
46. AGENDA
1. DEFINITIONS AND APPLICABLE REGULATIONS
2. INVESTIGATIONAL NEW DRUG (IND) PROCESS
3. INVESTIGATONAL DEVICE EXEMPTION (IDE) PROCESS
4. RESOURCES AVAILABLE
5.CASE EXAMPLES
47. Case Example
“A Phase I In-Vivo Esophageal Protocol for Detection of Neoplasia in the
Digestive Tract”
Develop the use of fluorescence-labeled peptides that affinity bind to pre-cancerous
mucosa (dysplastic Barrett’s Esophagus) in the digestive tract for use as an imaging
agent to guide endoscopic biopsy or endoscopic mucosal resection
Specific aims:
1) To evaluate the safety of topically administered fluorescence-labeled
peptides to the surface of esophageal mucosa.
2) To validate binding of the fluorescence-labeled peptide to esophageal
neoplasia.
Investigational study agent: fluorescent-labeled peptide composed of a 7-amino
acid chain attached to a substituted fluorescein derivative. The compound was
manufactured under current Good Manufacturing Practices (GMP).
48. Case Example
“A Phase I In-Vivo Colon Protocol for Detection of Neoplasia in the Digestive
Tract”
Develop the use of fluorescence-labeled peptides that affinity bind to pre-cancerous
mucosa in the digestive tract for use as an imaging agent to aid in the early
detection of colon cancer.
Specific Aims:
1) To evaluate the safety of topically administered fluorescence-labeled
peptides to the surface of intra-colonic mucosa.
2) To validate binding of the fluorescence-labeled peptide to intra-colonic
neoplasia.
Investigational Study Agent: fluorescence-labeled peptide composed of a 7-amino
acid chain attached to a substituted fluorescein derivative. The compound was
manufactured under current Good Manufacturing Practices (GMP).
49. 1. Sponsor
initiates
study
7. FDA
2. GMP synthesis
compound
21CFR 58
3. Analytical
validation of dose
range
4. Pharmacology &
Toxicology
6. Chemistry,
manufacturing,
control
5. Clinical
protocols
IND#110,444
IND#116,907
NTR industrial partners
provide novel imaging
instruments compatible
with molecular probes
to accelerate translation
into the clinic
NTR Standards & Compliance
Research Core provides guidance
for preparation of Investigation of
New Drug (IND) application to
FDA to perform Phase 1 clinical
study
fluorescence
white
light
biopsy
channel
light
guide
air/
water
light
guide
Bill Reisdorph, MIAP
Jin Ito, Olympus Medical
Network for Translational Research
National Cancer Institute
50. Meetings
with Industry
Partner
IND support
requested
Esophegeal
Phase I Study
Enrollment
Begins 2/2011
Esophageal
IND Submitted
11/2010
Colon IND
Submitted
11/2012
Colon
Phase I Study
Enrollment
Completed 8/2013
2009 2010 2011 2012 2013
Qualificaton
of GLP
vendors
Study Team
Planning
MILESTONES
Detection of Neoplasia in the Digestive Tract
FDA
Approval
12/2010
CMC docs
received from
GMP
manufacturer
FDA
Approval
12/2012
Esophageal
Phase Ib Study
Protocol
submitted
5/2012
Timeline
Colon
Phase I Study
Enrollment
Begins 2/2013
Esophageal
Phase I Study
Enrollment
completed
2/2013
Esophageal
Phase Ib Study
Enrollment
completed
9/2013