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An Overview of FDA Regulated Products : From Drugs and Cosmetics to Food and Tobacco.

By: Bain, Susan.
Contributor(s): Drago, Daniela | Pacifici, Eunjoo.
Material type: TextTextSeries: eBooks on Demand.Publisher: Saint Louis : Elsevier Science & Technology, 2018Copyright date: ©2018Description: 1 online resource (292 pages).Content type: text Media type: computer Carrier type: online resourceISBN: 9780128111567.Subject(s): United States.-Food and Drug Administration | New products-United States | Manufactures-United StatesGenre/Form: Electronic books.Additional physical formats: Print version:: An Overview of FDA Regulated Products : From Drugs and Cosmetics to Food and TobaccoDDC classification: 344.730423 Online resources: Click here to view this ebook.
Contents:
Cover -- Title page -- Copyright page -- Dedication -- Contents -- Contributors -- Foreword -- Preface -- Acknowledgments -- Chapter 1 - Introduction to FDA-regulated products -- Chapter objectives -- 1.1 - What is a regulated product? -- 1.2 - How are different products regulated? -- 1.3 - Product classification -- 1.4 - History of the modern regulatory system -- 1.4.1 - Adulteration and misbranding -- 1.4.2 - Safety -- 1.4.3 - Efficacy -- 1.4.4 - Regulation of medical devices -- 1.4.5 - User fees -- 1.5 - Focus on postmarketing oversight -- 1.6 - The modern regulatory system -- References -- Chapter 2 - Regulatory agencies of the ICH: authorities, structures, and functions -- Chapter objectives -- 2.1 - Introduction -- 2.2 - United states of america: food and drug administration -- 2.2.1 - Establishing a regulatory mechanism -- 2.2.2 - What is fda's mission? -- 2.2.3 - How is the fda structured? -- 2.2.4 - Medical products -- 2.2.5 - Legal framework -- 2.2.6 - Fda's functions -- 2.2.6.1 - Permitting unapproved products to undergo testing in humans -- 2.2.6.2 - Reviewing applications for marketing -- 2.2.6.2.1 - Drugs -- 2.2.6.2.2 - Biologics -- 2.2.6.2.3 - Medical devices -- 2.2.6.3 - Pharmacovigilance -- 2.2.7 - OTHER PRODUCTS -- 2.2.7.1 - Veterinary products -- 2.2.7.2 - Food -- 2.2.7.3 - Cosmetics -- 2.2.7.4 - Tobacco products -- 2.3 - JAPAN: PHARMACEUTICALS AND MEDICAL DEVICES AGENCY (PMDA) -- 2.3.1 - MISSION -- 2.3.1.1 - Reviews -- 2.3.1.2 - Safety measures -- 2.3.1.3 - Relief services for patients suffering from adverse health effects -- 2.3.2 - SCOPE -- 2.3.3 - ORGANIZATION STRUCTURE -- 2.3.4 - PRIMARY REGULATORY FUNCTIONS -- 2.3.5 - NOTEWORTHY REGULATORY PROVISIONS -- 2.3.5.1 - Special regulatory pathway for regenerative medicine -- 2.3.5.2 - Drug master file system -- 2.3.5.3 - Accelerated regulatory pathway for innovative products.
2.3.5.4 - Accredited foreign manufacturer -- 2.3.6 - MEDICAL DEVICES -- 2.3.7 - QUASIDRUGS -- 2.3.8 - COSMETICS -- 2.3.9 - ORPHAN PRODUCTS -- 2.3.10 - POSTMARKETING SAFETY MEASURE -- 2.3.10.1 - Early postmarketing phase vigilance -- 2.3.10.2 - Mihari project -- 2.3.10.3 - Relief services for adverse health effects -- 2.3.11 - REGULATORY SCIENCE -- 2.3.12 - INTERNATIONAL ACTIVITIES -- 2.3.13 - SUMMARY -- 2.4 - EUROPEAN UNION: EUROPEAN MEDICINES AGENCY -- 2.4.1 - MISSION AND SCOPE -- 2.4.2 - LEGAL FRAMEWORK -- 2.4.3 - CENTRALIZED PROCEDURE -- 2.4.3.1 - Biotechnology products -- 2.4.3.2 - Advanced therapies -- 2.4.3.3 - Selected indications -- 2.4.4 - CLINICAL TRIALS -- 2.4.4.1 - Investigational medicinal product application -- 2.4.5 - MEDICAL DEVICES -- 2.4.6 - PHARMACOVIGILANCE -- 2.4.6.1 - Risk management plan (EMA, 2016m) -- 2.4.6.2 - Qualified person of pharmacovigilance (QPPV) -- 2.4.7 - SUMMARY -- 2.5 - ROLE OF CIOMS AND ICH -- 2.5.1 - CIOMS -- 2.5.2 - ICH -- 2.6 - OVERALL SUMMARY -- References -- Further ReadingS -- Chapter 3 - Drugs -- Chapter Objectives -- 3.1 - Is the product a drug? -- 3.2 - How are drugs categorized? -- 3.3 - What is a regulatory strategy and what does it entail? -- 3.3.1 - The target product indication -- 3.3.2 - The target patient population -- 3.3.3 - The FDA-expedited programs -- 3.3.4 - The target markets -- 3.4 - What are the key steps of a new drug development process? -- 3.4.1 - The discovery of a drug candidate -- 3.4.2 - The nonclinical phase of drug development -- 3.4.2.1 - Pharmacology -- 3.4.2.2 - Pharmacokinetics -- 3.4.2.3 - Toxicology -- 3.4.2.4 - Estimation of the first dose in humans -- 3.4.3 - The clinical phases of drug development -- 3.4.3.1 - Study design -- 3.4.3.2 - Study phases -- 3.4.3.2.1 - Phase 1 studies -- 3.4.3.2.2 - Phase 2 studies -- 3.4.3.2.3 - Phase 3 studies (pivotal trials).
3.4.4 - The chemistry, manufacturing, and controls component of drug development -- 3.5 - What are the key steps of a new drug approval process in the United States? -- 3.5.1 - The standard NDA process -- 3.5.2 - The FDA-accelerated pathways -- 3.6 - What happens after a drug product receives regulatory approval? -- 3.7 - How is a new drug developed and approved in international markets? -- 3.7.1 - Key considerations for starting clinical trials in international markets -- 3.7.1.1 - Europe -- 3.7.1.2 - Japan -- 3.7.1.3 - China -- 3.7.2 - The regulatory approval process in international markets -- 3.7.2.1 - Europe -- 3.7.2.1.1 - European MA procedures -- 3.7.2.2 - Japan -- 3.7.2.3 - China -- 3.8 - What are the key steps of a generic drug development and approval process? -- 3.8.1 - The ANDA pathway -- 3.8.2 - The concept of bioequivalence -- 3.8.3 - Differences between the "generics" and the "505(B)(2)" pathways -- 3.9 - What are the key steps of an Over-the-Counter (OTC) drug development and approval process? -- 3.9.1 - The monograph process -- 3.9.2 - The process for Rx-to-OTC switch -- References -- Chapter 4 - Biologics -- Chapter Objectives -- 4.1 - What is a biologic? -- 4.2 - Which center at the fda regulates biologics? Cber or cder? -- 4.3 - What is fda's role regarding biological products? -- 4.4 - How do biologics differ from conventional drugs? -- 4.4.1 - Manufacturing, quality, and controls -- 4.4.2 - Preclinical development -- 4.4.2.1 - Species selection -- 4.4.2.2 - Study design, route, and dose selection -- 4.4.2.3 - Immunogenicity -- 4.4.3 - Clinical development -- 4.5 - The regulatory pathways (how do i bring a new biologic to approval?) -- 4.5.1 - Innovative and expedited pathways -- 4.6 - Submission and review process -- 4.6.1 - United States -- 4.6.2 - Europe -- 4.6.3 - Rest of World -- 4.7 - Postmarketing activities.
4.8 - Special topics -- 4.8.1 - Biosimilars -- 4.8.2 - Vaccines -- 4.9 - Conclusions -- References -- Further Readings -- Chapter 5 - Medical device and diagnostic products -- Chapter Objectives -- 5.1 - Regulating devices in the United States -- 5.1.1 - Do I have a medical device? -- 5.1.2 - How do I classify my device? -- 5.1.2.1 - Class I devices -- 5.1.2.2 - Class II devices -- 5.1.2.3 - Class III devices -- 5.1.3 - How do I find out my device class? -- 5.1.4 - What is a de novo submission? -- 5.1.5 - Reducing the burden for products with a small market -- 5.2 - Recent initiatives to encourage innovation -- 5.3 - Regulatory strategy -- 5.3.1 - Managing the design phase -- 5.4 - Assuring compliant manufacturing -- 5.4.1 - Assuring compliance with QSRs -- 5.4.2 - Developing contracts with CMOs and vendors -- 5.5 - Conducting clinical trials -- 5.5.1 - Investigational device exemption -- 5.6 - Gaining regulatory approval -- 5.6.1 - Postmarket management -- 5.6.1.1 - Reporting and acting on adverse events and complaints -- 5.6.1.2 - Field corrections and recalls -- 5.6.1.3 - Complaints -- 5.7 - Medical device regulation in other countries -- 5.7.1 - Europe -- 5.7.2 - Japan -- 5.7.3 - China -- 5.7.4 - Canada -- 5.8 - In vitro diagnostics-a special type of medical device -- 5.8.1 - General purpose reagents -- 5.8.2 - Analyte-specific reagents -- 5.8.3 - Premarket submissions for IVDs -- 5.8.3.1 - IVDs subject to premarket notification-510(k) -- 5.8.3.2 - Premarket approval-PMA -- 5.8.4 - IVDs subject to humanitarian device exemption -- 5.8.5 - Investigational device exemption -- 5.8.6 - Labeling requirements for IVDs -- 5.8.7 - Postmarket requirements for IVDs -- 5.8.8 - Challenges faced by manufacturers -- 5.8.8.1 - Regulation of laboratory developed tests -- 5.8.8.2 - Regulation of emerging technologies -- 5.9 - International regulation of IVDs.
5.9.1 - Europe -- 5.9.2 - Japan -- 5.9.3 - China -- 5.9.4 - Canada -- Further Readings -- Chapter 6 - Combination products, borderline products, and companion diagnostics -- Chapter Objectives -- 6.1 - What is a combination product or a companion diagnostic and why are these types of products so important? -- 6.2 - Challenges for the regulation and classification of combination products and companion diagnostics -- 6.3 - Us perspective -- 6.3.1 - Classification -- 6.3.2 - Designation process -- 6.3.3 - Borderline cases-request for designation -- 6.3.4 - Regulatory approval process -- 6.3.5 - Data requirements -- 6.4 - European perspective -- 6.4.1 - Risk classification of medical devices -- 6.4.2 - Combination products and their regulation in europe -- 6.4.3 - Approval process for a medical device containing ancillary drug/human blood derivative (ce certification) -- 6.4.4 - Approval process for a medicinal product with an integral drug delivery system -- 6.5 - The proposed medical device regulation -- 6.6 - Regulation of companion diagnostics -- 6.6.1 - Us perspective -- 6.6.2 - European perspective -- 6.7 - Conclusions -- References -- Chapter 7 - Food -- Chapter Objectives -- 7.1 - Food regulatory history -- 7.2 - Which agency is responsible for regulating food? -- 7.2.1 - FDA -- 7.2.2 - USDA -- 7.2.3 - FSIS -- 7.2.4 - EPA -- 7.2.5 - FWS -- 7.2.6 - TTB -- 7.2.7 - DEA -- 7.3 - Key food regulatory standards -- 7.3.1 - Food Safety Modernization Act -- 7.3.2 - Cottage food operations (state-specific) -- 7.3.3 - Food defect action levels (21CFR110.110) -- 7.3.4 - Flavor safety -- 7.4 - Adulteration -- 7.5 - Misbranded -- 7.6 - What is healthy? -- 7.7 - Natural -- 7.8 - Organic -- 7.9 - Nutrition labeling (USA) -- 7.10 - Functional foods (USA) -- 7.11 - Health claims -- 7.12 - BE Labeling -- 7.13 - Safety assessment (GRAS).
7.14 - New dietary ingredient.
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Cover -- Title page -- Copyright page -- Dedication -- Contents -- Contributors -- Foreword -- Preface -- Acknowledgments -- Chapter 1 - Introduction to FDA-regulated products -- Chapter objectives -- 1.1 - What is a regulated product? -- 1.2 - How are different products regulated? -- 1.3 - Product classification -- 1.4 - History of the modern regulatory system -- 1.4.1 - Adulteration and misbranding -- 1.4.2 - Safety -- 1.4.3 - Efficacy -- 1.4.4 - Regulation of medical devices -- 1.4.5 - User fees -- 1.5 - Focus on postmarketing oversight -- 1.6 - The modern regulatory system -- References -- Chapter 2 - Regulatory agencies of the ICH: authorities, structures, and functions -- Chapter objectives -- 2.1 - Introduction -- 2.2 - United states of america: food and drug administration -- 2.2.1 - Establishing a regulatory mechanism -- 2.2.2 - What is fda's mission? -- 2.2.3 - How is the fda structured? -- 2.2.4 - Medical products -- 2.2.5 - Legal framework -- 2.2.6 - Fda's functions -- 2.2.6.1 - Permitting unapproved products to undergo testing in humans -- 2.2.6.2 - Reviewing applications for marketing -- 2.2.6.2.1 - Drugs -- 2.2.6.2.2 - Biologics -- 2.2.6.2.3 - Medical devices -- 2.2.6.3 - Pharmacovigilance -- 2.2.7 - OTHER PRODUCTS -- 2.2.7.1 - Veterinary products -- 2.2.7.2 - Food -- 2.2.7.3 - Cosmetics -- 2.2.7.4 - Tobacco products -- 2.3 - JAPAN: PHARMACEUTICALS AND MEDICAL DEVICES AGENCY (PMDA) -- 2.3.1 - MISSION -- 2.3.1.1 - Reviews -- 2.3.1.2 - Safety measures -- 2.3.1.3 - Relief services for patients suffering from adverse health effects -- 2.3.2 - SCOPE -- 2.3.3 - ORGANIZATION STRUCTURE -- 2.3.4 - PRIMARY REGULATORY FUNCTIONS -- 2.3.5 - NOTEWORTHY REGULATORY PROVISIONS -- 2.3.5.1 - Special regulatory pathway for regenerative medicine -- 2.3.5.2 - Drug master file system -- 2.3.5.3 - Accelerated regulatory pathway for innovative products.

2.3.5.4 - Accredited foreign manufacturer -- 2.3.6 - MEDICAL DEVICES -- 2.3.7 - QUASIDRUGS -- 2.3.8 - COSMETICS -- 2.3.9 - ORPHAN PRODUCTS -- 2.3.10 - POSTMARKETING SAFETY MEASURE -- 2.3.10.1 - Early postmarketing phase vigilance -- 2.3.10.2 - Mihari project -- 2.3.10.3 - Relief services for adverse health effects -- 2.3.11 - REGULATORY SCIENCE -- 2.3.12 - INTERNATIONAL ACTIVITIES -- 2.3.13 - SUMMARY -- 2.4 - EUROPEAN UNION: EUROPEAN MEDICINES AGENCY -- 2.4.1 - MISSION AND SCOPE -- 2.4.2 - LEGAL FRAMEWORK -- 2.4.3 - CENTRALIZED PROCEDURE -- 2.4.3.1 - Biotechnology products -- 2.4.3.2 - Advanced therapies -- 2.4.3.3 - Selected indications -- 2.4.4 - CLINICAL TRIALS -- 2.4.4.1 - Investigational medicinal product application -- 2.4.5 - MEDICAL DEVICES -- 2.4.6 - PHARMACOVIGILANCE -- 2.4.6.1 - Risk management plan (EMA, 2016m) -- 2.4.6.2 - Qualified person of pharmacovigilance (QPPV) -- 2.4.7 - SUMMARY -- 2.5 - ROLE OF CIOMS AND ICH -- 2.5.1 - CIOMS -- 2.5.2 - ICH -- 2.6 - OVERALL SUMMARY -- References -- Further ReadingS -- Chapter 3 - Drugs -- Chapter Objectives -- 3.1 - Is the product a drug? -- 3.2 - How are drugs categorized? -- 3.3 - What is a regulatory strategy and what does it entail? -- 3.3.1 - The target product indication -- 3.3.2 - The target patient population -- 3.3.3 - The FDA-expedited programs -- 3.3.4 - The target markets -- 3.4 - What are the key steps of a new drug development process? -- 3.4.1 - The discovery of a drug candidate -- 3.4.2 - The nonclinical phase of drug development -- 3.4.2.1 - Pharmacology -- 3.4.2.2 - Pharmacokinetics -- 3.4.2.3 - Toxicology -- 3.4.2.4 - Estimation of the first dose in humans -- 3.4.3 - The clinical phases of drug development -- 3.4.3.1 - Study design -- 3.4.3.2 - Study phases -- 3.4.3.2.1 - Phase 1 studies -- 3.4.3.2.2 - Phase 2 studies -- 3.4.3.2.3 - Phase 3 studies (pivotal trials).

3.4.4 - The chemistry, manufacturing, and controls component of drug development -- 3.5 - What are the key steps of a new drug approval process in the United States? -- 3.5.1 - The standard NDA process -- 3.5.2 - The FDA-accelerated pathways -- 3.6 - What happens after a drug product receives regulatory approval? -- 3.7 - How is a new drug developed and approved in international markets? -- 3.7.1 - Key considerations for starting clinical trials in international markets -- 3.7.1.1 - Europe -- 3.7.1.2 - Japan -- 3.7.1.3 - China -- 3.7.2 - The regulatory approval process in international markets -- 3.7.2.1 - Europe -- 3.7.2.1.1 - European MA procedures -- 3.7.2.2 - Japan -- 3.7.2.3 - China -- 3.8 - What are the key steps of a generic drug development and approval process? -- 3.8.1 - The ANDA pathway -- 3.8.2 - The concept of bioequivalence -- 3.8.3 - Differences between the "generics" and the "505(B)(2)" pathways -- 3.9 - What are the key steps of an Over-the-Counter (OTC) drug development and approval process? -- 3.9.1 - The monograph process -- 3.9.2 - The process for Rx-to-OTC switch -- References -- Chapter 4 - Biologics -- Chapter Objectives -- 4.1 - What is a biologic? -- 4.2 - Which center at the fda regulates biologics? Cber or cder? -- 4.3 - What is fda's role regarding biological products? -- 4.4 - How do biologics differ from conventional drugs? -- 4.4.1 - Manufacturing, quality, and controls -- 4.4.2 - Preclinical development -- 4.4.2.1 - Species selection -- 4.4.2.2 - Study design, route, and dose selection -- 4.4.2.3 - Immunogenicity -- 4.4.3 - Clinical development -- 4.5 - The regulatory pathways (how do i bring a new biologic to approval?) -- 4.5.1 - Innovative and expedited pathways -- 4.6 - Submission and review process -- 4.6.1 - United States -- 4.6.2 - Europe -- 4.6.3 - Rest of World -- 4.7 - Postmarketing activities.

4.8 - Special topics -- 4.8.1 - Biosimilars -- 4.8.2 - Vaccines -- 4.9 - Conclusions -- References -- Further Readings -- Chapter 5 - Medical device and diagnostic products -- Chapter Objectives -- 5.1 - Regulating devices in the United States -- 5.1.1 - Do I have a medical device? -- 5.1.2 - How do I classify my device? -- 5.1.2.1 - Class I devices -- 5.1.2.2 - Class II devices -- 5.1.2.3 - Class III devices -- 5.1.3 - How do I find out my device class? -- 5.1.4 - What is a de novo submission? -- 5.1.5 - Reducing the burden for products with a small market -- 5.2 - Recent initiatives to encourage innovation -- 5.3 - Regulatory strategy -- 5.3.1 - Managing the design phase -- 5.4 - Assuring compliant manufacturing -- 5.4.1 - Assuring compliance with QSRs -- 5.4.2 - Developing contracts with CMOs and vendors -- 5.5 - Conducting clinical trials -- 5.5.1 - Investigational device exemption -- 5.6 - Gaining regulatory approval -- 5.6.1 - Postmarket management -- 5.6.1.1 - Reporting and acting on adverse events and complaints -- 5.6.1.2 - Field corrections and recalls -- 5.6.1.3 - Complaints -- 5.7 - Medical device regulation in other countries -- 5.7.1 - Europe -- 5.7.2 - Japan -- 5.7.3 - China -- 5.7.4 - Canada -- 5.8 - In vitro diagnostics-a special type of medical device -- 5.8.1 - General purpose reagents -- 5.8.2 - Analyte-specific reagents -- 5.8.3 - Premarket submissions for IVDs -- 5.8.3.1 - IVDs subject to premarket notification-510(k) -- 5.8.3.2 - Premarket approval-PMA -- 5.8.4 - IVDs subject to humanitarian device exemption -- 5.8.5 - Investigational device exemption -- 5.8.6 - Labeling requirements for IVDs -- 5.8.7 - Postmarket requirements for IVDs -- 5.8.8 - Challenges faced by manufacturers -- 5.8.8.1 - Regulation of laboratory developed tests -- 5.8.8.2 - Regulation of emerging technologies -- 5.9 - International regulation of IVDs.

5.9.1 - Europe -- 5.9.2 - Japan -- 5.9.3 - China -- 5.9.4 - Canada -- Further Readings -- Chapter 6 - Combination products, borderline products, and companion diagnostics -- Chapter Objectives -- 6.1 - What is a combination product or a companion diagnostic and why are these types of products so important? -- 6.2 - Challenges for the regulation and classification of combination products and companion diagnostics -- 6.3 - Us perspective -- 6.3.1 - Classification -- 6.3.2 - Designation process -- 6.3.3 - Borderline cases-request for designation -- 6.3.4 - Regulatory approval process -- 6.3.5 - Data requirements -- 6.4 - European perspective -- 6.4.1 - Risk classification of medical devices -- 6.4.2 - Combination products and their regulation in europe -- 6.4.3 - Approval process for a medical device containing ancillary drug/human blood derivative (ce certification) -- 6.4.4 - Approval process for a medicinal product with an integral drug delivery system -- 6.5 - The proposed medical device regulation -- 6.6 - Regulation of companion diagnostics -- 6.6.1 - Us perspective -- 6.6.2 - European perspective -- 6.7 - Conclusions -- References -- Chapter 7 - Food -- Chapter Objectives -- 7.1 - Food regulatory history -- 7.2 - Which agency is responsible for regulating food? -- 7.2.1 - FDA -- 7.2.2 - USDA -- 7.2.3 - FSIS -- 7.2.4 - EPA -- 7.2.5 - FWS -- 7.2.6 - TTB -- 7.2.7 - DEA -- 7.3 - Key food regulatory standards -- 7.3.1 - Food Safety Modernization Act -- 7.3.2 - Cottage food operations (state-specific) -- 7.3.3 - Food defect action levels (21CFR110.110) -- 7.3.4 - Flavor safety -- 7.4 - Adulteration -- 7.5 - Misbranded -- 7.6 - What is healthy? -- 7.7 - Natural -- 7.8 - Organic -- 7.9 - Nutrition labeling (USA) -- 7.10 - Functional foods (USA) -- 7.11 - Health claims -- 7.12 - BE Labeling -- 7.13 - Safety assessment (GRAS).

7.14 - New dietary ingredient.

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