Author: Mindy J. Allport-Settle
Publisher: Pharmalogika
ISBN: 9780983071907
Category : Law
Languages : en
Pages : 672
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Book Description
This book is designed to be a unified reference source for the U.S. Federal Food, Drug, and Cosmetic Act and is designed to be used both as a reference for experienced industry representatives and as a training resource for those new to the industry. Federal Food, Drug, and Cosmetic Act: * Introduction to the FDA and the FD&C Act * Part I: Federal Food, Drug, and Cosmetic Act o Section Number Reference: Federal Food, Drug, and Cosmetic Act o FD&C Act Chapters I and II: Short Title and Definitions o FD&C Act Chapter III: Prohibited Acts and Penalties o FD&C Act Chapter IV: FoodFD&C Act Chapter V: Drugs and Devices o FD&C Act Chapter VI: Cosmetics o FD&C Act Chapter VII: General Authority o FD&C Act Chapter VIII: Imports and Exports o FD&C Act Chapter IX: MiscellaneousSignificant Amendments to the FD&C Act Reference Tools * Part II: Combined Glossary and Index for all Regulations
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Food
Languages : en
Pages : 116
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Book Description
Author: Stephen M. Kanovsky
Publisher:
ISBN: 9781935065876
Category : Drugs
Languages : en
Pages : 672
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Book Description
FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.
Author: ADAM I. MUCHMORE
Publisher:
ISBN: 9781531004453
Category :
Languages : en
Pages : 734
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Book Description
Author: Upton Sinclair
Publisher:
ISBN:
Category : Chicago (Ill.)
Languages : en
Pages : 442
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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Book Description
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Author: Eunjoo Pacifici
Publisher: Academic Press
ISBN: 0128111569
Category : Medical
Languages : en
Pages : 292
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Book Description
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. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
Author: United States. Congress. Senate. Committee on Commerce
Publisher:
ISBN:
Category : Cosmetics industry
Languages : en
Pages : 520
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Book Description
Considers legislation to prevent sale and false advertising of adulterated and misbranded food, drugs, and cosmetics.
Author: United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher:
ISBN:
Category : Advertising
Languages : en
Pages : 32
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Book Description
Author: United States
Publisher:
ISBN:
Category : Cosmetics
Languages : en
Pages : 156
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Book Description
