Guidebook for Drug Regulatory Submissions
(Sprache: Englisch)
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.
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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.
Klappentext zu „Guidebook for Drug Regulatory Submissions “
Destined to become every regulatory director's essential desktop companionrofessionals 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.
- Provides regulatory professionals with the key tools necessary to submit major documents to the United States Food and Drug Administration
- Offers clear guidance and recommendations for effective submission of documents for the required regulatory reviews during drug development
- Assists any company or individual (US or internationally-based) in navigating the complexities of getting FDA approval for producing and marketing drugs in the United States
- Compiles relevant documents and procedures for drug regulatory submissions
- Offers clear guidance and recommendations for effective submission of documents for the required regulatory reviews during drug development
- Assists any company or individual (US or internationally-based) in navigating the complexities of getting FDA approval for producing and marketing drugs in the United States
- Compiles relevant documents and procedures for drug regulatory submissions
Inhaltsverzeichnis zu „Guidebook for Drug Regulatory Submissions “
Chapter 1. Ten Rules for Drug Regulatory SubmissionsChapter 2. FDA Meeting Requests
Chapter 3. Orphan Drug Applications
Chapter 4. Investigatory New Drug Applications (INDs)
Chapter 5. New Drug Applications (NDAs)
Chapter 6. 505(b)2 New Drug Applications
Chapter 7. Abbreviated New Drug Applications (ANDAs)
Chapter 8. Annual Reports
Chapter 9. International Submissions (Carl A. Rockburne)
Chapter 10. Future Issues in Regulatory Submissions
Autoren-Porträt von Sandy Weinberg
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.
Bibliographische Angaben
- Autor: Sandy Weinberg
- 2009, 1. Auflage, 400 Seiten, Maße: 16,1 x 24 cm, Gebunden, Englisch
- Verlag: Wiley & Sons
- ISBN-10: 0470371382
- ISBN-13: 9780470371381
- Erscheinungsdatum: 25.02.2009
Sprache:
Englisch
Rezension zu „Guidebook for Drug Regulatory Submissions “
"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)
Pressezitat
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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