Guidebook for Drug Regulatory Submissions / Edition 1

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Overview

Professionals working to submit major documents to the Food and Drug Administration (FDA) are guaranted to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.
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Editorial Reviews

From the Publisher
“The Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.” (Pharmaceutical Outsourcing, April 2009)
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Product Details

  • ISBN-13: 9780470371381
  • Publisher: Wiley
  • Publication date: 3/11/2009
  • Edition description: New Edition
  • Edition number: 1
  • Pages: 379
  • Product dimensions: 6.30 (w) x 9.30 (h) x 2.80 (d)

Table of Contents

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 Carl A. Rockburne 315

Chapter 10 Future Issues in Regulatory Submissions 355

Index 367

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