Guidebook for Drug Regulatory Submissions

by Weinberg, Sandy

• ISBN13: 9780470371381
• ISBN10: 0470371382
• eBook ISBN(s): 9780470456170
• Edition: 1st
• Format: Hardcover
• Copyright: 2009-03-11
• Publisher: Wiley
• More Book Details
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Summary

The high-stakes process of submitting drug documents and applications for regulatory review can be intimidating, particularly for the inexperienced regulatory professional charged with preparing a major regulatory submission. This book provides regulatory professionals with the key tools necessary to submit major documents to the United States Food and Drug Administration. The book consists of thirteen chapters, including an introductory and conclusion chapter and 11 units, each consisting of an introductory essay, submission checklist, evaluation checklist giving guidance on FDA criteria, and copies of relevant FDA documents.

Author Biography

SANDY WEINBERG is the former Vice President for Regulatory Affairs and Quality Assurance at Tikvah Therapeutics, Inc., and is now Associate Professor of Health Care Management and Director of the Master in Health Administration Graduate Program at Clayton State University in Atlanta. He has thirty years of experience in the field of drug regulatory affairs and is the author of twelve books, most recently Good Laboratory Practice Regulations, Fourth Edition.

Table of Contents

Preface	p. ix
Ten Rules for Drug Regulatory Submissions	p. 1
FDA Meeting Requests	p. 44
Orphan-Drug Applications	p. 64
Investigational New Drug Applications (INDs)	p. 82
New Drug Applications (NDAs)	p. 120
505(b)2 New Drug Applications (NDAs)	p. 183
Abbreviated New Drug Applications (ANDAs)	p. 255
Annual Reports	p. 288
International Regulatory Submissions	p. 315
Future Issues in Regulatory Submissions	p. 355
Index	p. 367
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