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An overview of FDA regulated product...

Bain, Susan,

An overview of FDA regulated products :from drugs and cosmetics to food and tobacco /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	An overview of FDA regulated products :edited by Eunjoo Pacifici, Susan Bain.
其他題名:	from drugs and cosmetics to food and tobacco /
其他作者:	Pacifici, Eunjoo,
面頁冊數:	1 online resource
標題:	New productsUnited States.
電子資源:	https://www.sciencedirect.com/science/book/9780128111550
ISBN:	9780128111567$q(electronic bk.)

An overview of FDA regulated products :from drugs and cosmetics to food and tobacco /
An overview of FDA regulated products :from drugs and cosmetics to food and tobacco /edited by Eunjoo Pacifici, Susan Bain. - 1 online resource

Includes bibliographical references and index.

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.

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.

ISBN: 9780128111567$q(electronic bk.)Subjects--Corporate Names:

239985
United States.
Food and Drug Administration.Subjects--Topical Terms:

846442
New products
--United States.Index Terms--Genre/Form:

214472
Electronic books.

LC Class. No.: HF5415.153

Dewey Class. No.: 658.5/75

An overview of FDA regulated products :from drugs and cosmetics to food and tobacco /
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505 0 $a 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.
505 8 $a 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.
505 8 $a 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.
505 8 $a 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.
505 8 $a 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?
505 8 $a 3.3 -- What is a regulatory strategy and what does it entail?
520 $a 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.
610 1 0 $a United States. $b Food and Drug Administration. $3 239985
650 0 $a New products $z United States. $3 846442
650 0 $a Manufactures $z United States. $3 846443
655 4 $a Electronic books. $2 local. $3 214472
700 1 $a Pacifici, Eunjoo, $e editor. $3 846440
700 1 $a Bain, Susan, $e editor. $3 846441
856 4 0 $u https://www.sciencedirect.com/science/book/9780128111550