| Description |
1 online resource (xxi, 268 pages) |
| 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 |
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Chapter 2 -- Regulatory agencies of the ICH: authorities, structures, and functionsChapter 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 |
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2.2.7 -- OTHER PRODUCTS2.2.7.1 -- 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 |
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2.3.5.3 -- Accelerated regulatory pathway for innovative products2.3.5.4 -- 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 |
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2.4.3.1 -- Biotechnology products2.4.3.2 -- 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? |
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3.3 -- What is a regulatory strategy and what does it entail? |
| Summary |
Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Online resource; title from PDF title page (EBSCO, viewed June 21, 2018) |
| Subject |
United States. Food and Drug Administration.
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| SUBJECT |
United States. Food and Drug Administration fast |
| Subject |
New products -- United States
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Manufactures -- United States.
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Cosmetics.
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Food.
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Tobacco.
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Device Approval
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Drug Approval
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Consumer Product Safety
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Cosmetics
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Food
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Government Regulation
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Nicotiana
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cosmetics.
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food.
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tobacco (material)
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BUSINESS & ECONOMICS -- Industrial Management.
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BUSINESS & ECONOMICS -- Management.
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BUSINESS & ECONOMICS -- Management Science.
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BUSINESS & ECONOMICS -- Organizational Behavior.
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Tobacco
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Food
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Cosmetics
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Manufactures
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New products
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United States
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| Form |
Electronic book
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| Author |
Pacifici, Eunjoo, editor
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Bain, Susan, editor
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| ISBN |
9780128111567 |
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0128111569 |
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