Founded by Dr. Robert S. McQuate and Dr. Richard C. Kraska, two seasoned regulatory veterans with over 60 years’ collective experience working for and with the FDA, GRAS Associates provides customized food safety and compliance regulatory consulting solutions for products regulated by the U.S. Food and Drug Administration (FDA), including products which may be considered to be Generally Recognized as Safe (GRAS).
The term GRAS, Generally Recognized as Safe, has been in the news quite a bit lately. But there still isn’t much clarity what GRAS really means, who oversees GRAS efforts, and what “safe” actually means.
Join us for a webinar with Jim Lassiter, COO, of Ingredient Identity, which a firm is committed to providing Food, Animal and Dietary Supplement, Homeopathic, and Cosmetic companies with exceptional FDA regulatory consulting and quality support services.
On this webinar Jim will discuss GRAS and NDIN (New Dietary Ingredients Notification) strategies for ingredient innovators and suppliers.
Learn about:
-Industry insights
-Regulatory challenges
-Current agency positions
-Guidance to help you avoid major and predictable pitfalls, and how to evaluate timing and define the appropriate budgets.
This document summarizes a discussion draft from the Pew Charitable Trusts providing guidance for industry on selecting experts to conduct Generally Recognized as Safe (GRAS) evaluations. The draft was created to address conflicts of interest identified in Pew's previous research. It outlines four key questions around purpose, exemptions, comparisons to similar programs, and resources. If finalized, the guidance would provide recommendations to the FDA on implementing their 2010 recommendation to develop a strategy to minimize potential conflicts of interest in GRAS determinations.
The document outlines the multi-step process for developing new drugs, which includes discovery, preclinical testing on cells and animals, and clinical trials with human subjects in 4 phases. It takes an average of 6.5 years and over $500 million to develop a new drug, with only 1 in 1000 potential compounds making it through the rigorous testing process. The clinical trials are designed with safety protections for research volunteers and oversight from regulatory agencies like the FDA.
The 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) includes a provision that allows sponsors to request that their drug be designated as a "Breakthrough Therapy". This designation is primarily based on the early clinical finding of substantial efficacy in s serious medical need indication. A Breakthrough Therapy Designation provides fast track program advantages alongside a frequent FDA guidance on an efficient drug development program. The FDA also makes an organizational commitment to involve experienced reviewers and senior management in such guidance. This presentation provides an overview of Breakthrough Therapy Designation and discusses why CMC aspects can lag-behind clinical development and how this may be addressed.
The time has come to seriously work on leveraging End-of-Phase II for setting regulatory specifications.
Breakthrough Therapy Designation- Spring 2014 Reg. IntelligenceCharles Kemmerer
Breakthrough Therapy Designation is a process created by the FDA to expedite the development and review of drugs for serious conditions. It requires preliminary clinical evidence that the drug may demonstrate substantial improvement over existing therapies. This allows drugs to be submitted for approval based on smaller trials. Benefits of designation include intensive FDA guidance, involvement of senior managers, and potentially reaching the market 3 years faster than standard approval. However, the designation may be removed if later trials do not confirm preliminary results. As of September 2013, 40 drugs had received this designation from the FDA.
The document summarizes a presentation on the pharmaceutical regulatory science landscape in 2015. It discusses:
1) Changes and emerging trends in regulatory sciences, including increased globalization and harmonization efforts.
2) Quality metrics and using data to understand industry performance and identify issues.
3) Shifting business models, including more outsourcing and the need for continuous quality improvements.
4) Ensuring data integrity and addressing challenges like lack of integrity raising doubts about safety.
The Small Company Clinical Study SponsorRoles & Duties Vis-à-vis LiabilityMichael Swit
This document summarizes a presentation given by Michael Swit on roles and responsibilities of small company clinical trial sponsors and how to minimize liability when outsourcing clinical trial activities. Key points discussed include clarifying what sponsors are responsible for versus outsourcing partners, ensuring compliance of outsourcing partners, maintaining oversight of critical trial activities in-house, and explaining to funders that quality must be prioritized over cost.
FSMA FridayIs a Return to Normalcy in Sight? (Vaccine Updates and More)SafetyChain Software
What to Know About Virus Variants, New Vaccine Efficacies & Availability, and a Roundup of Ways Manufacturing Has Changed Since COVID-19 with Renowned Epidemiologist Ben Miller, Ph.D., MPH, from The Acheson Group.
The term GRAS, Generally Recognized as Safe, has been in the news quite a bit lately. But there still isn’t much clarity what GRAS really means, who oversees GRAS efforts, and what “safe” actually means.
Join us for a webinar with Jim Lassiter, COO, of Ingredient Identity, which a firm is committed to providing Food, Animal and Dietary Supplement, Homeopathic, and Cosmetic companies with exceptional FDA regulatory consulting and quality support services.
On this webinar Jim will discuss GRAS and NDIN (New Dietary Ingredients Notification) strategies for ingredient innovators and suppliers.
Learn about:
-Industry insights
-Regulatory challenges
-Current agency positions
-Guidance to help you avoid major and predictable pitfalls, and how to evaluate timing and define the appropriate budgets.
This document summarizes a discussion draft from the Pew Charitable Trusts providing guidance for industry on selecting experts to conduct Generally Recognized as Safe (GRAS) evaluations. The draft was created to address conflicts of interest identified in Pew's previous research. It outlines four key questions around purpose, exemptions, comparisons to similar programs, and resources. If finalized, the guidance would provide recommendations to the FDA on implementing their 2010 recommendation to develop a strategy to minimize potential conflicts of interest in GRAS determinations.
The document outlines the multi-step process for developing new drugs, which includes discovery, preclinical testing on cells and animals, and clinical trials with human subjects in 4 phases. It takes an average of 6.5 years and over $500 million to develop a new drug, with only 1 in 1000 potential compounds making it through the rigorous testing process. The clinical trials are designed with safety protections for research volunteers and oversight from regulatory agencies like the FDA.
The 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) includes a provision that allows sponsors to request that their drug be designated as a "Breakthrough Therapy". This designation is primarily based on the early clinical finding of substantial efficacy in s serious medical need indication. A Breakthrough Therapy Designation provides fast track program advantages alongside a frequent FDA guidance on an efficient drug development program. The FDA also makes an organizational commitment to involve experienced reviewers and senior management in such guidance. This presentation provides an overview of Breakthrough Therapy Designation and discusses why CMC aspects can lag-behind clinical development and how this may be addressed.
The time has come to seriously work on leveraging End-of-Phase II for setting regulatory specifications.
Breakthrough Therapy Designation- Spring 2014 Reg. IntelligenceCharles Kemmerer
Breakthrough Therapy Designation is a process created by the FDA to expedite the development and review of drugs for serious conditions. It requires preliminary clinical evidence that the drug may demonstrate substantial improvement over existing therapies. This allows drugs to be submitted for approval based on smaller trials. Benefits of designation include intensive FDA guidance, involvement of senior managers, and potentially reaching the market 3 years faster than standard approval. However, the designation may be removed if later trials do not confirm preliminary results. As of September 2013, 40 drugs had received this designation from the FDA.
The document summarizes a presentation on the pharmaceutical regulatory science landscape in 2015. It discusses:
1) Changes and emerging trends in regulatory sciences, including increased globalization and harmonization efforts.
2) Quality metrics and using data to understand industry performance and identify issues.
3) Shifting business models, including more outsourcing and the need for continuous quality improvements.
4) Ensuring data integrity and addressing challenges like lack of integrity raising doubts about safety.
The Small Company Clinical Study SponsorRoles & Duties Vis-à-vis LiabilityMichael Swit
This document summarizes a presentation given by Michael Swit on roles and responsibilities of small company clinical trial sponsors and how to minimize liability when outsourcing clinical trial activities. Key points discussed include clarifying what sponsors are responsible for versus outsourcing partners, ensuring compliance of outsourcing partners, maintaining oversight of critical trial activities in-house, and explaining to funders that quality must be prioritized over cost.
FSMA FridayIs a Return to Normalcy in Sight? (Vaccine Updates and More)SafetyChain Software
What to Know About Virus Variants, New Vaccine Efficacies & Availability, and a Roundup of Ways Manufacturing Has Changed Since COVID-19 with Renowned Epidemiologist Ben Miller, Ph.D., MPH, from The Acheson Group.
The document describes an upcoming summit hosted by the Avoca Quality Consortium in 2013. The Consortium brings together quality, outsourcing, and operational professionals from pharmaceutical, biotech, and clinical research organizations to develop best practices for proactive quality management in outsourced clinical trials. The summit will feature sessions on finding the right balance between timelines, costs, and quality in clinical trials, and will include discussions on effective oversight, risk assessment, risk management, and culture in ensuring quality. Industry leaders will also discuss key imperatives for quality moving forward.
Data Integrity Validation Keynote Address Boston August 2016Ajaz Hussain
The document provides an overview of a keynote presentation on data integrity and compliance. It discusses evaluating the global regulatory landscape on data integrity expectations, the 2016 FDA draft guidance on data integrity, and overcoming top challenges. It also addresses proactively assuring data integrity and achieving an effective culture of pharmaceutical quality. The presentation examines increasing breaches of data integrity noted in FDA warning letters and inspections globally.
How to establish and maintain a great working (3))Jerome Gainer
Regulatory agencies play an important role in animal health. To establish and maintain good relationships with them, companies should:
1) Make it a top priority and demonstrate competence, honesty and respect in all communications. Provide supporting documentation and take responsibility to correct any issues.
2) Become familiar with each agency's priorities and challenges. Attend stakeholder meetings to better understand their perspectives.
3) Express appreciation for their help and strive for win-win solutions. Pick battles carefully while advocating for logical, science-based positions. Maintain an accurate record of all interactions.
FDA Enforcement & Compliance for Medical DevicesMichael Swit
Presentation to the Food & Drug Law Institute (FDLI) Introduction to Medical Device Law, with a focus on:
* FDA Jurisdiction to Enforce
* Prohibited Acts and Penalties
* Inspections – FDA’s Prime Enforcement Tool
* Other “Cops on the Beat”
* Commissioner Hamburg’s Enforcement Initiative
How to establish and maintain a great working (3))Jerome Gainer
Establishing and maintaining good relationships with regulatory agencies is important. Three things to do are: 1) demonstrate competence through clear, well-organized communication; 2) respect the expertise of regulators and be honest about any problems; and 3) express appreciation to regulators. It is also important to be familiar with each agency's priorities and requirements. Overall the goal should be win-win solutions through logical, science-based arguments while avoiding hostile comments.
The document outlines the key responsibilities of sponsors in clinical research. Sponsors initiate clinical investigations and are ultimately responsible for the quality and integrity of the research. They can transfer duties like protocol design and monitoring to contract research organizations but remain accountable. Sponsors must ensure proper quality assurance and control, select qualified investigators, and manage trial conduct, data handling, and independent oversight committees. They are also responsible for regulatory approvals, safety monitoring, audits, and reporting results.
Preparing to comply with the new fda fsma rules planning valid preventive foo...GlobalCompliancePanel
Validation of preventive controls is where the rubber meets the road in terms of prevention. You can develop a food safety plan, implement the plan and verify the plan, but if your data does not prove that you are actually preventing food safety problems
Lucinda Fasig is a Clinical Research Associate with over 20 years of experience in clinical research. She has experience monitoring clinical trials to ensure compliance with regulations and guidelines. Her responsibilities include implementing and monitoring trials, qualifying investigative sites, reviewing data for accuracy, and completing required documentation. Previously she has held roles as a Clinical Research Regulatory Specialist, Oncology Clinical Research Coordinator, and Quality Assurance Auditor conducting audits of clinical trials. She has extensive training and is certified as a Clinical Research Coordinator.
Amit Kumar is a pharmacovigilance professional with over 6 years of experience. He currently works as an Assistant Manager at Tata Consultancy Services in Pune, India. Some of his key responsibilities include processing and quality reviewing ICSR, legal, and clinical trial cases. He also has experience writing PSUR/PADER/PBRER/DSUR reports. Previously he has worked at Cognizant Technology Solutions and Claris Lifesciences in pharmacovigilance roles. He holds an M.Pharm and B.Pharm from Birla Institute of Technology.
Anthony Presentation DIA Florida Ctd Nov2007AKTaylor
Creating a business process that is accurate, predictable, and capable of
meeting the changing needs for disclosing information about clinical trials
in multiple study registries and results databases is difficult. Companies
need to leverage their current clinical trial process, determine if the disclosure
steps will be centralized or decentralized, determine how much to
leverage technology, and decide whether, and how, to use outside
resources. During this session, we will hear how a large pharma, a small
biopharmaceutical company, and a device company developed their clinical
trial disclosure business process.
Presentation at ACI Conference on FDA Enforcement, covered:
Warning Letters, FDA Case Referral Process/Role of DOJ and U.S. Attorney, Coordination with States, Collateral Consequences of FDA Enforcement Actions
Pharma-CRO Relationships Managing Risk A Lawyer\'s Viewalbinpaul
The document discusses sponsor-CRO relationships and managing risks when outsourcing clinical trials to contract research organizations (CROs). It defines CROs and site management organizations (SMOs) and their roles. It also discusses selecting CROs, establishing metrics to measure performance, managing personnel changes and communications, and proactively avoiding and resolving disputes. The key aspects are selecting the right CRO based on expertise and compatibility, establishing metrics for accountability and continuous improvement, and clear communications and dispute resolution processes to facilitate the relationship.
A Food Ingredient’s Journey to Your Dinner TableFood Insight
Today’s foods and beverages contain many different ingredients that perform a variety of specific functions, including to improve our food’s taste, texture, nutrition, convenience, safety, and affordability. While there is more than one path to determine an ingredient’s safety, their safety mustbe established before they can be added to foods and beverages. Let’s follow a food ingredient’s journey to your dinner table.
Ensuring Compliance with U.S. FDA Cosmetics RegulationsRegistrar Corp
For more than a decade, Registrar Corp has offered businesses its dedicated assistance in complying with U.S. Food and Drug Administration (FDA) regulations. Spanning 16 offices across the globe, Hampton, Virginia-based Registrar Corp has extensive experience in the food and beverage, drug, medical device, and cosmetics sectors. Registrar Corp employees consist of a number of scientists and other regulatory specialists who have formerly worked for the FDA.
The U.S. Federal Food, Drug and Cosmetic Act1 (FFDCA) provides for two regulatory mechanisms for the addition of substances to foods.
They are the food additive petition process and the Generally Recognized as Safe (GRAS) process. GRAS is unique to the U.S. and is sometimes not well understood.
Though not official, the IFAC GRAS Best Practices Guide is intended to serve as a compilation of available U.S.
Food and Drug Administration (FDA) regulations, guidance documents and industry best practices to help determine the GRAS status of a substance
Generally Recognized as Safe or GRAS is an FDA designation for a substance that it considers as safe.
FDA stands for the Food and Drug Administration. The FDA is a federal agency of the United States that is responsible for protecting and promoting public health.
GRAS is an acronym.
Therefore, we pronounced the letters as a word. In other words, we do not say ‘G-R-A-S’ (we do not utter each letter’s name separately).
Are you searching for a Regulatory Compliance Consultant that can help you acquire a Natural Product Number (NPN) for your NHP product? If so, Quality Smart Solutions is the right place. QSS is a renowned global consulting firm with a successful track record of registering more than 5,000 NPNs since inception. This company helps meet compliant bilingual label requirements and an Importer of Recorder. Get assistance in preparing a Product license application (PLA), Electronic Product License Application (ePLA) for a class 1 or 2 NHP, Electronic Product License Application for a class 3 NHP, an Evidence Summary Report (it includes information for safety and efficacy support) and a finished product specification form.
For more information about Regulatory Compliance Service at Quality Smart Solutions, visit the official website https://qualitysmartsolutions.com/.
This document discusses the role of drug regulatory affairs personnel in liaising with regulatory agencies like the US FDA. It provides background on the FDA, including that it is responsible for food, drug, medical device and cosmetic safety. It also outlines some FDA initiatives to expedite drug approval processes, such as alternative pathways. Finally, it stresses that regulatory professionals must be aware of FDA guidance documents and recommends experience liaising with global regulatory agencies through meetings and courses to aid new product development.
August 29, 2012 presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Review Course, with a focus on:
* new animal drug applications
* generic new animal drugs applications
* species and uses
George A. Burdock, Ph.D. of Burdock Group Consultations explains the regulatory approval process for animal feed and pet food ingredients, detailing the process of food additive petitions, GRAS reviews and notifications, and AFCOO definitions.
FDA & Health Canada (CFIA) Requirements to Sell Foods in North AmericaQuality Smart Solutions
This food compliance webinar focuses on food labelling requirements, TMAL, requirements to import or export food. U.S Agent, FSVP agent and more.
Visit:
https://qualitysmartsolutions.com/food-beverage-regulatory-compliance-canada/
https://qualitysmartsolutions.com/food-beverage-regulatory-compliance-canada/
The document provides an overview of the US Food and Drug Administration (FDA) regulatory structure and processes. It discusses that the FDA is responsible for food, drug, medical device and cosmetic safety. It also outlines the FDA organization, initiatives to expedite drug approvals, and guidance documents available. Regulatory professionals must understand FDA expectations to facilitate new product development and approval. Effective liaison with the FDA and a thorough knowledge of global regulatory systems are essential for regulatory success.
This document provides an overview of U.S. regulations for novel food ingredients, including food additives, GRAS substances, dietary supplements, and case studies on specific emerging technologies like genetically modified plants, cell-based and plant-based meats, and animal food ingredients. It describes the regulatory authorities of the FDA and USDA and various approval pathways including food additive petitions, GRAS notifications, and AAFCO new ingredient definitions.
The document describes an upcoming summit hosted by the Avoca Quality Consortium in 2013. The Consortium brings together quality, outsourcing, and operational professionals from pharmaceutical, biotech, and clinical research organizations to develop best practices for proactive quality management in outsourced clinical trials. The summit will feature sessions on finding the right balance between timelines, costs, and quality in clinical trials, and will include discussions on effective oversight, risk assessment, risk management, and culture in ensuring quality. Industry leaders will also discuss key imperatives for quality moving forward.
Data Integrity Validation Keynote Address Boston August 2016Ajaz Hussain
The document provides an overview of a keynote presentation on data integrity and compliance. It discusses evaluating the global regulatory landscape on data integrity expectations, the 2016 FDA draft guidance on data integrity, and overcoming top challenges. It also addresses proactively assuring data integrity and achieving an effective culture of pharmaceutical quality. The presentation examines increasing breaches of data integrity noted in FDA warning letters and inspections globally.
How to establish and maintain a great working (3))Jerome Gainer
Regulatory agencies play an important role in animal health. To establish and maintain good relationships with them, companies should:
1) Make it a top priority and demonstrate competence, honesty and respect in all communications. Provide supporting documentation and take responsibility to correct any issues.
2) Become familiar with each agency's priorities and challenges. Attend stakeholder meetings to better understand their perspectives.
3) Express appreciation for their help and strive for win-win solutions. Pick battles carefully while advocating for logical, science-based positions. Maintain an accurate record of all interactions.
FDA Enforcement & Compliance for Medical DevicesMichael Swit
Presentation to the Food & Drug Law Institute (FDLI) Introduction to Medical Device Law, with a focus on:
* FDA Jurisdiction to Enforce
* Prohibited Acts and Penalties
* Inspections – FDA’s Prime Enforcement Tool
* Other “Cops on the Beat”
* Commissioner Hamburg’s Enforcement Initiative
How to establish and maintain a great working (3))Jerome Gainer
Establishing and maintaining good relationships with regulatory agencies is important. Three things to do are: 1) demonstrate competence through clear, well-organized communication; 2) respect the expertise of regulators and be honest about any problems; and 3) express appreciation to regulators. It is also important to be familiar with each agency's priorities and requirements. Overall the goal should be win-win solutions through logical, science-based arguments while avoiding hostile comments.
The document outlines the key responsibilities of sponsors in clinical research. Sponsors initiate clinical investigations and are ultimately responsible for the quality and integrity of the research. They can transfer duties like protocol design and monitoring to contract research organizations but remain accountable. Sponsors must ensure proper quality assurance and control, select qualified investigators, and manage trial conduct, data handling, and independent oversight committees. They are also responsible for regulatory approvals, safety monitoring, audits, and reporting results.
Preparing to comply with the new fda fsma rules planning valid preventive foo...GlobalCompliancePanel
Validation of preventive controls is where the rubber meets the road in terms of prevention. You can develop a food safety plan, implement the plan and verify the plan, but if your data does not prove that you are actually preventing food safety problems
Lucinda Fasig is a Clinical Research Associate with over 20 years of experience in clinical research. She has experience monitoring clinical trials to ensure compliance with regulations and guidelines. Her responsibilities include implementing and monitoring trials, qualifying investigative sites, reviewing data for accuracy, and completing required documentation. Previously she has held roles as a Clinical Research Regulatory Specialist, Oncology Clinical Research Coordinator, and Quality Assurance Auditor conducting audits of clinical trials. She has extensive training and is certified as a Clinical Research Coordinator.
Amit Kumar is a pharmacovigilance professional with over 6 years of experience. He currently works as an Assistant Manager at Tata Consultancy Services in Pune, India. Some of his key responsibilities include processing and quality reviewing ICSR, legal, and clinical trial cases. He also has experience writing PSUR/PADER/PBRER/DSUR reports. Previously he has worked at Cognizant Technology Solutions and Claris Lifesciences in pharmacovigilance roles. He holds an M.Pharm and B.Pharm from Birla Institute of Technology.
Anthony Presentation DIA Florida Ctd Nov2007AKTaylor
Creating a business process that is accurate, predictable, and capable of
meeting the changing needs for disclosing information about clinical trials
in multiple study registries and results databases is difficult. Companies
need to leverage their current clinical trial process, determine if the disclosure
steps will be centralized or decentralized, determine how much to
leverage technology, and decide whether, and how, to use outside
resources. During this session, we will hear how a large pharma, a small
biopharmaceutical company, and a device company developed their clinical
trial disclosure business process.
Presentation at ACI Conference on FDA Enforcement, covered:
Warning Letters, FDA Case Referral Process/Role of DOJ and U.S. Attorney, Coordination with States, Collateral Consequences of FDA Enforcement Actions
Pharma-CRO Relationships Managing Risk A Lawyer\'s Viewalbinpaul
The document discusses sponsor-CRO relationships and managing risks when outsourcing clinical trials to contract research organizations (CROs). It defines CROs and site management organizations (SMOs) and their roles. It also discusses selecting CROs, establishing metrics to measure performance, managing personnel changes and communications, and proactively avoiding and resolving disputes. The key aspects are selecting the right CRO based on expertise and compatibility, establishing metrics for accountability and continuous improvement, and clear communications and dispute resolution processes to facilitate the relationship.
A Food Ingredient’s Journey to Your Dinner TableFood Insight
Today’s foods and beverages contain many different ingredients that perform a variety of specific functions, including to improve our food’s taste, texture, nutrition, convenience, safety, and affordability. While there is more than one path to determine an ingredient’s safety, their safety mustbe established before they can be added to foods and beverages. Let’s follow a food ingredient’s journey to your dinner table.
Ensuring Compliance with U.S. FDA Cosmetics RegulationsRegistrar Corp
For more than a decade, Registrar Corp has offered businesses its dedicated assistance in complying with U.S. Food and Drug Administration (FDA) regulations. Spanning 16 offices across the globe, Hampton, Virginia-based Registrar Corp has extensive experience in the food and beverage, drug, medical device, and cosmetics sectors. Registrar Corp employees consist of a number of scientists and other regulatory specialists who have formerly worked for the FDA.
The U.S. Federal Food, Drug and Cosmetic Act1 (FFDCA) provides for two regulatory mechanisms for the addition of substances to foods.
They are the food additive petition process and the Generally Recognized as Safe (GRAS) process. GRAS is unique to the U.S. and is sometimes not well understood.
Though not official, the IFAC GRAS Best Practices Guide is intended to serve as a compilation of available U.S.
Food and Drug Administration (FDA) regulations, guidance documents and industry best practices to help determine the GRAS status of a substance
Generally Recognized as Safe or GRAS is an FDA designation for a substance that it considers as safe.
FDA stands for the Food and Drug Administration. The FDA is a federal agency of the United States that is responsible for protecting and promoting public health.
GRAS is an acronym.
Therefore, we pronounced the letters as a word. In other words, we do not say ‘G-R-A-S’ (we do not utter each letter’s name separately).
Are you searching for a Regulatory Compliance Consultant that can help you acquire a Natural Product Number (NPN) for your NHP product? If so, Quality Smart Solutions is the right place. QSS is a renowned global consulting firm with a successful track record of registering more than 5,000 NPNs since inception. This company helps meet compliant bilingual label requirements and an Importer of Recorder. Get assistance in preparing a Product license application (PLA), Electronic Product License Application (ePLA) for a class 1 or 2 NHP, Electronic Product License Application for a class 3 NHP, an Evidence Summary Report (it includes information for safety and efficacy support) and a finished product specification form.
For more information about Regulatory Compliance Service at Quality Smart Solutions, visit the official website https://qualitysmartsolutions.com/.
This document discusses the role of drug regulatory affairs personnel in liaising with regulatory agencies like the US FDA. It provides background on the FDA, including that it is responsible for food, drug, medical device and cosmetic safety. It also outlines some FDA initiatives to expedite drug approval processes, such as alternative pathways. Finally, it stresses that regulatory professionals must be aware of FDA guidance documents and recommends experience liaising with global regulatory agencies through meetings and courses to aid new product development.
August 29, 2012 presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Review Course, with a focus on:
* new animal drug applications
* generic new animal drugs applications
* species and uses
George A. Burdock, Ph.D. of Burdock Group Consultations explains the regulatory approval process for animal feed and pet food ingredients, detailing the process of food additive petitions, GRAS reviews and notifications, and AFCOO definitions.
FDA & Health Canada (CFIA) Requirements to Sell Foods in North AmericaQuality Smart Solutions
This food compliance webinar focuses on food labelling requirements, TMAL, requirements to import or export food. U.S Agent, FSVP agent and more.
Visit:
https://qualitysmartsolutions.com/food-beverage-regulatory-compliance-canada/
https://qualitysmartsolutions.com/food-beverage-regulatory-compliance-canada/
The document provides an overview of the US Food and Drug Administration (FDA) regulatory structure and processes. It discusses that the FDA is responsible for food, drug, medical device and cosmetic safety. It also outlines the FDA organization, initiatives to expedite drug approvals, and guidance documents available. Regulatory professionals must understand FDA expectations to facilitate new product development and approval. Effective liaison with the FDA and a thorough knowledge of global regulatory systems are essential for regulatory success.
This document provides an overview of U.S. regulations for novel food ingredients, including food additives, GRAS substances, dietary supplements, and case studies on specific emerging technologies like genetically modified plants, cell-based and plant-based meats, and animal food ingredients. It describes the regulatory authorities of the FDA and USDA and various approval pathways including food additive petitions, GRAS notifications, and AAFCO new ingredient definitions.
The document discusses the importance of regulatory affairs in the pharmaceutical industry. It describes how regulatory affairs acts as the bridge between pharmaceutical companies and government regulatory agencies by ensuring drug products meet all necessary quality, safety, and efficacy standards before and after approval. Key responsibilities of regulatory affairs include managing clinical trials and submissions, maintaining compliance with all regulations, and advising companies on regulatory requirements and strategies. Strict regulations are necessary to protect public health after past drug failures and disasters.
The Application Integrity Policy (AIP): A Little History.Michael Swit
This document summarizes the FDA's Application Integrity Policy (AIP), which was established in 1991 in response to fraud in generic drug applications. The AIP allows the FDA to defer review of any application where they have questions about the reliability of the data, until those questions are resolved. Companies that fall under the AIP must cooperate with investigators, identify wrongdoers, conduct an internal review, and submit a corrective action plan signed by the CEO to address procedures and controls to prevent future issues. Few companies have survived being placed on the AIP, as it often coincides with criminal prosecution and civil litigation that can damage a company.
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry since supplements are classified as foods rather than drugs. This could allow unsafe products to reach consumers without proper testing or oversight. The authors propose several steps for the FDA to take including implementing pre-market regulations to review products for safety, educating consumers, and increasing independent case studies to hold manufacturers accountable. The goal is to ensure supplements are reliable and consumers can make informed choices to avoid potential health issues like mortality from overuse or contaminated products.
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry, despite supplements sometimes having detrimental health effects. The authors propose that the FDA implement pre-market regulations and testing of supplements, educate consumers, and conduct more case studies to hold manufacturers accountable and remove unsafe products from the market. This would help ensure that supplements are reliable and that consumers are informed of benefits and risks.
This document discusses regulations for nutraceuticals in India and the United States. It provides an overview of the key regulatory bodies - the FSSAI in India and DSHEA in the US. Requirements for product registration are outlined for both countries, including necessary documentation like application forms, labeling details, and evidence of safety. While regulations differ between the two locations, the goal in each is to ensure nutraceutical products are safely manufactured and their claims are truthful.
Marketing FDA Regulated Products Through Social MediaAnita Anzo
Scheduled On Wednesday, October 9, 2013 at 01:00 PM EDT
Duration: 90 minutes
This webinar is recorded
visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1103
The document discusses Risk Evaluation and Mitigation Strategies (REMS), which were introduced by the FDA Amendments Act of 2007. REMS allow the FDA to require risk management plans from drug manufacturers to ensure that a drug's benefits outweigh its risks. The document outlines the various elements that can be required in a REMS, including medication guides, communication plans, and elements to assure safe use like restricted distribution and registries. It also discusses factors the FDA considers in determining whether a REMS is needed and the experience with the first drugs approved with a REMS.
How can Food Safety Practitioners prepare for the FSMA Regulations?Beth Mitchell
The document discusses how food safety practitioners can prepare for new FSMA regulations. Key points:
1) The FSMA represents the biggest reform of US food safety laws in over 70 years, shifting the focus from responding to contamination to preventing it.
2) The new regulations include requirements for hazard analysis and preventive controls, environmental monitoring, supplier verification, recall plans, and ensuring qualified staff.
3) Companies must improve processes, documentation, communication and ensure competent staff understand hazards and controls to comply with the risk-based regulations. Independent certification helps verify effectiveness and drive continuous improvement.
Fda gmp compliance for the Life Science Industrydmanalan
The document discusses good manufacturing practices (GMP) required by the FDA for life science companies. It provides an overview of GMP regulations for drugs, medical devices, and combination products. It explains that the FDA focuses on a "state of control" during inspections to assess compliance. While drug GMPs and device quality system regulations differ in some details, the overall systems are similar. The document reviews how the regulations address statistical techniques and quality systems. It also outlines the FDA's systems-based approach to inspections.
Similar to GRAS Associates Corporate Overview (20)
Omega 3 additional ingredients and stability monitoringNutrasource
This document discusses quality control and stability testing for omega-3 products. It outlines challenges in testing omega-3 due to its oil-based matrix and susceptibility to oxidation. Common quality control tests for omega-3 include acid value, peroxide value, p-anisidine value, and quantitative assays using GC or LC-MS. Stability studies evaluate products under various temperature and humidity conditions over time. Oxidation is the primary degradation pathway and difficult to quantify due to complex degradation product mixtures. Quality by design principles aim to develop robust analytical methods, evaluate compatibility, and set specifications to ensure product quality and stability.
Diteba is a global leader in complex analytical and bioanalytical testing, providing solutions and services to the pharmaceutical, biopharmaceutical and nutraceutical industries.
We support both large and small molecule testing for various dosage forms including solids, semi-solids, liquids, aerosols and other special dosage forms. Our work is focused in several core areas including: In Vitro Release Rate Testing (IVRT) services; stability storage and testing; method development and validation and QC testing at our fully accredited facility.
In this presentation, you'll learn more about Nutrasource, a contract research organization and consulting from that provides a vertically integrated, virtual R&D consulting service platform for the entire consumer health products industry.
The Value of Product-Specific Data for Marketing and Sales ROINutrasource
As regulatory requirements for foods and health products tighten across the world and product categories become increasingly competitive, more companies than ever are investing in research and development (R&D) to help their products stay novel, comply with regulations and stand out in the marketplace. Product-specific data is the common and trending theme that meets these objectives. In order to generate this data successfully and within budget, companies must ensure they are maximizing their return on investment (ROI) as it relates to product sales and marketing. This lecture will provide you with valuable information about the value of product-specific data for marketing and sales, and discuss specific strategies your company can use to maximize your return on this investment.
Novel Approaches to Omega-3 Stability Testing Nutrasource
In the last decade, nutritional oil products such as omega-3s have grown to a multi-billion dollar industry globally. As a result, new analytical testing challenges have arisen from the current trend toward producing more attractive and more appetizing products created for a wider consumer base.
In formulating these "new and improved," better looking and better tasting products, different color and flavor additives are used, which can interfere with the most popular analytical procedure for determining the secondary oxidation of nutritional oil products, the p-anisidine value test.
In order to overcome these analytical challenges, a new alternative method for testing these additive-laden products has been established and is ready for use in this fast growing marketing segment.
Dr. Steven Li provides details about the latest innovation in omega-3 testing and its application in the omega-3 industry, at GOED Exchange 2014.
The International Fish Oil Standards (IFOS) Program: An OverviewNutrasource
The International Fish Oil Standards (IFOS) Program is the only third party testing and certification program for the fish oil industry. We help companies add market value to their brands so that they stand out on the shelf as symbols of purity, safety and stability. www.ifosprogram.com
A Global Perspective on Food Health Claims Nutrasource
On Wednesday, August 21st, Pulse Canada hosted an expert panel workshop in Toronto on the potential for a health claim related to Lentils and Post-prandial Glycaemia in Toronto. Invited delegates to the workshop included over 30 representatives from the pulse industry, food industry, academia as well as and regulatory experts. The purpose of the workshop was to provide a forum in which to discuss a systematic literature review that was conducted in 2012 by Nutrasource Diagnostics Inc (NDI) with respect to achieving a health claim related to lentils and short term blood sugar control in Canada, the US or the EU.
Krista Coventry from NDI presented a background on the regulatory frameworks in Canada, the US, the EU and Australia/New Zealand.
Heritage Conservation.Strategies and Options for Preserving India HeritageJIT KUMAR GUPTA
Presentation looks at the role , relevance and importance of built and natural heritage, issues faced by heritage in the Indian context and options which can be leveraged to preserve and conserve the heritage.It also lists the challenges faced by the heritage due to rapid urbanisation, land speculation and commercialisation in the urban areas. In addition, ppt lays down the roadmap for the preservation, conservation and making value addition to the available heritage by making it integral part of the planning , designing and management of the human settlements.
3. GRAS Associates – Your Partners in Food Safety
www.diteb.com
• Founded by Dr. Robert S. McQuate and Dr. Richard C.
Kraska, two seasoned regulatory veterans with over
60 years’ collective experience working for and with
the FDA, GRAS Associates provides customized food
safety and compliance regulatory consulting
solutions for products regulated by the U.S. Food and
Drug Administration (FDA), including products which
may be considered to be Generally Recognized as
Safe (GRAS)
www.gras-associates.com GRAS ASSOCIATES LLC
4. GRAS Associates – Your Partners in Food Safety
www.diteb.com
• As the functional food industry continues to grow,
and new additives are being investigated, GRAS
ingredients have become more valuable
• Our experienced team of scientists in the fields of
toxicology, microbiology, biochemistry and regulatory
compliance can assist you with bringing your product
to market and meeting U.S. FDA regulations
www.gras-associates.com GRAS ASSOCIATES LLC
5. GRAS Associates – Your Partners in Food Safety
www.diteb.com
• We specialize in preparing self-determined and FDA-
notified GRAS submissions as well as regulatory
compliance reviews for dietary supplements and
medical foods
• Areas of specialization include:
• Generally Recognized as Safe (GRAS) ingredients
• Medical Food Ingredients
• Food contact notifications
• Animal Feed Ingredients
• New Dietary Ingredient Notifications
• Food Additives
• 21 CGR Part 110 and 111 cGMP compliance Strategies
• Infant Formula ingredient Compliance
www.gras-associates.com GRAS ASSOCIATES LLC
6. GRAS Associates – Your Partners in Food Safety
www.diteb.com
Through our successful delivery of GRAS evaluations and
ingredient safety assessments, our clients gain access to
greater marketplace opportunities through innovative
and expanded product offerings
Our years of experience guarantees efficient and cost-
effective solutions to enter new markets, introduce
new products and comply with changes in the
regulatory landscape.
www.gras-associates.com GRAS ASSOCIATES LLC
7. GRAS Associates – Your Partners in Food Safety
www.diteb.com
GRAS Associates has submitted approximately
15% of all GRAS notices received by the FDA since
the company was founded in 2008, with a 90%
success rate
www.gras-associates.com GRAS ASSOCIATES LLC
9. Dr. Richard Kraska, Ph.D., DBAT
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
Dr. Richard Kraska began his career at FDA in food additives and moved on to
GRAS Review. At FDA, he participated in safety evaluations on sensitive topics
such as aspartame, cyclamate and salt. For the next twenty-two years he had
numerous assignments with three major chemical companies where he
integrated critical toxicology aspects into a wide variety of regulatory
matters. This included intensive coordination with corporate
acquisitions. Since becoming an independent consultant, Richard as helped
dozens of clients with product safety and regulatory projects covering food
additives, food processing aids, animal feed additives and food packaging
materials.
10. Dr. Robert McQuate, Ph.D.
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
Dr. Robert McQuate started his regulatory career within FDA's GRAS Review
Branch prior to serving in technical management positions in the private sector
with The Dial Company and the National Soft Drink Association. While in the
private sector, he addressed numerous high visibility food safety issues
including caloric and non-nutritive sweeteners, sulfiting agents, and caffeine.
As an independent consultant since 1988, Robert has assisted scores of clients
from North America, Asia, and Europe achieve marketplace success for their
food products and dietary supplements by fostering the acquisition of the
scientific documentation to fulfill the requisite regulatory requirements.
11. Cheryl Dicks, MS, RAC
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
Cheryl has 30 years of experience in business management and product quality
management and over 14 years of experience in FDA regulatory in supplement,
nutraceutical, pharmaceutical and device development. She has been involved
in the successful submission of all phases of clinical development Phase I
through IV to the FDA and has established relationships with federal
representatives at the FDA and represented a diverse sponsor base in Orphan
Drug designations, Type A, B and C meetings, fast track designation and
medical devices. Additionally, Cheryl is regarded as an industry expert on
Quality Management Systems connecting GCP and GLP for RAPS
webcast. Cheryl has been a lecturer for Biomedical and Regulatory Affairs at
Hood College as well as a researcher and clinical trial project leader with the US
Army Medical Research and Medical Command.
13. What is GRAS status?
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
• GRAS is an acronym for Generally Recognized as Safe
• It is a regulatory designation set by the U.S. Food and Drug
Administration (FDA) that applies to any substance intentionally
added to a food (e.g., a food additive)
• First introduced as part of the 1985 Food Additives Amendment to
the Federal Food, Drug and Cosmetic Act (FD&C Act)
• In order to be compliant with the FDA's regulations, companies
typically choose the GRAS determination pathway for a substance if
they feel there is substantial consensus among scientific experts,
outside the FDA, that the ingredient is safe for use as intended.
• GRAS determinations are performed by appropriately qualified
scientific entities, such as GRAS Associates, on behalf of sponsoring
firms.
14. Why secure GRAS status for an
ingredient?
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
• According to the FDA, "any substance that is
intentionally added to food is a food additive, that is
subject to premarket review and approval by FDA,
unless the substance is generally recognized, among
qualified experts, as having been adequately shown to
be safe under the conditions of its intended use, or
unless the use of the substance is otherwise excluded
from the definition of a food additive."
15. How to secure GRAS status
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
• To attain GRAS status for an ingredient, the sponsor must be
able to demonstrate that the substance in question is not likely
to cause harm when used as intended. This requires a
complete review of the safety evidence for the ingredient and
the submission of a GRAS filing with the FDA. The findings
result in establishing compliance with FDA regulations for the
food ingredient.
• A GRAS determination can be either self-determined,
independent of the FDA, or submitted to the FDA in the form of
a notification for the Agency’s assessment.
17. Other Regulatory Services
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
In addition to helping companies secure GRAS status for their ingredient, GRAS
Associates offers an array of focused food safety consulting services that assist
clients to obtain, maintain and defend GRAS opinions for success in the
marketplace. These services include:
• New Dietary Ingredient Notifications (NDIN)
• Regulatory Compliance and Product Development Consulting
• Medical Foods Compliance
• Food and Color Additive Petitions
• Food Contact Notifications (FCN)
• cGMP Compliance
• Technical Writing
• Literature Surveillance
• Research & Product Testing
18. New Dietary Ingredient Notification (NDIN)
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
Section 413(c) of the Federal Food, Drug, and Cosmetic Act requires the
submission of a notification for a dietary ingredient that was not marketed in
the United States as a dietary supplement before October 15, 1994.
The NDI notification process is complex. In fact, more than 80% of NDI
notifications are rejected by the FDA. The team at GRAS Associations is well
versed with NDI requirements and has assisted many clients in preparing and
submitting notifications.
Ensure the information needed to prepare and submit your
NDIN is complete to an exceptional degree of quality
19. Regulatory Compliance and Product
Development Consulting
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
With the FDA, the Federal Trade Commission (FTC) and other regulators and
lawmakers strictly enforcing regulations, food and dietary supplement
organizations today must use discretion when it comes to ensuring compliance.
Regulatory compliance and product development issues are extremely complex
and without a thorough understanding of today’s regulatory landscape, many
organizations are unable to succeed.
Let us support your regulatory and product development
efforts to gain a competitive edge while remaining compliant
with industry regulations
20. Medical Foods Compliance
www.diteb.com
Medical foods have become a hot product category in recent years. The FDA
defines medical foods as foods “formulated to be consumed or administered
enterally under the supervision of a physician and which is intended for the
specific dietary management of a disease or condition for which distinctive
nutritional requirements, based on recognized scientific principles, are
established by medical evaluation.”
While medical foods do not require pre-market approval by the FDA, they must
comply with all applicable FDA requirements for foods.
www.gras-associates.com GRAS ASSOCIATES LLC
Have the confidence that your medical food is compliant with
FDA requirements before going to market
21. Food Additive and Color Petitions
www.diteb.com
Not every GRAS determination is successful and some substances are more
suited for food additive petitions. A similar petition process is available for
color additives that are intended to impart color to foods, drugs, cosmetics and
medical devices.
www.gras-associates.com GRAS ASSOCIATES LLC
We will guide you through the FDA review process and ensure
that your food additive or color petition documentation is
complete to the highest level of quality and compliance
22. Food Contact Notifications
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
Food contact materials are intended or have the potential to come in contact
with food. When these materials come in contact with food, there is the
possibility of the chemical substances migrating from the food contact material
to the food, which could be potentially harmful to human health.
Consequently, many regulatory bodies have implemented food contact
regulations to ensure food safety.
We deliver comprehensive regulatory support to help you
submit food contact notifications.
23. It’s time to discover your full
market potential
Partner with GRAS Associates to uncover greater
market opportunities through innovative,
expanded product offerings – starting with food
safety and regulatory compliance.
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
Contact us today at info@gras-associates.com to discuss
your product goals.