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Guidebook for Drug Regulatory Submissions

Sandy Weinberg
ISBN: 978-0-470-37138-1
Hardcover
392 pages
March 2009
List Price: US $133.00
Government Price: US $92.12
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Preface ix

Chapter 1 Ten Rules for Drug Regulatory Submissions 1

Chapter 2 FDA Meeting Requests 44

Chapter 3 Orphan-Drug Applications 64

Chapter 4 Investigational New Drug Applications (INDs) 82

Chapter 5 New Drug Applications (NDAs) 120

Chapter 6 505(b)2 New Drug Applications (NDAs) 183

Chapter 7 Abbreviated New Drug Applications (ANDAs) 255

Chapter 8 Annual Reports 288

Chapter 9 International Regulatory Submissions 315
Carl A. Rockburne

Chapter 10 Future Issues in Regulatory Submissions 355

Index 367

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