Guidebook for Drug Regulatory Submissions

ISBN-13: 9780470371381 / Angielski / Twarda / 2009 / 392 str.

Sandy Weinberg

Opis

Destined to become every regulatory director's essential desktop companion rofessionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed 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. Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines. As well, vital information is provided on the most common types of submissions, including:

• Meeting Requests
• Orphan Drug Applications
• Investigatory New Drug Applications (INDAs)
• New Drug Applications (NDAs)
• 505(b)2 NDAs
• Abbreviated New Drug Applications (ANDAs)
• Annual Report

This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia. Guidebook for Drug Regulatory Submissions is more than a useful guide--it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.

Recenzje

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)

Spis treści

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

O autorze

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.

Blurb

Destined to become every regulatory director′s essential desktop companion

Professionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed 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.

Demystifying this complex, high–stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines.

As well, vital information is provided on the most common types of submissions, including:

• Meeting Requests
• Orphan Drug Applications
• Investigatory New Drug Applications (INDAs)
• New Drug Applications (NDAs)
• 505(b)2 NDAs
• Abbreviated New Drug Applications (ANDAs)
• Annual Report

This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest–authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia.

Guidebook for Drug Regulatory Submissions is more than a useful guide it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.