Hoboken, New Jersey-April 22, 2009- The GUIDEBOOK FOR DRUG REGULATORY SUBMISSIONS (Wiley-Blackwell; $99.95; March 2009) by Dr. Sandy Weinberg is 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. 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.
Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert, Dr. 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.
Vital information is provided on the most common types of submissions, including:
- FDA 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 tool 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 in the near future. In addition, retired Canadian trade consul and regulatory consultant, Carl Rockburne, contributes a chapter comparing the FDA process to the four other major regulatory environments: Canada, the European Union, Japan, and Australia.
The 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.
GUIDEBOOK FOR DRUG REGULATORY SUBMISSIONS
By Sandy Weinberg
Hardcover: ISBN: 978-0-470-37138-1; 379 pp.; $99.95; March 2009
About the Author
Dr. 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, Georgia. 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.
About Wiley-Blackwell
Wiley-Blackwell is the international scientific, technical, medical and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world's leading societies. Wiley-Blackwell publishes over 1,400 peer-reviewed journals as well as 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit www.wileyblackwell.com or www.interscience.wiley.com.