Guidebook for drug regulatory submissions
Sandy Weinberg · 2009
Where to buy
Amazon’s price changes daily, so the most accurate place to see it is there, at the moment you buy.
View on AmazonAbout the book
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. This book provides regulatory professionals with the key tools necessary to submit major documents to the United States Food and Drug Administration. The book consists of thirteen chapters, including an introductory and conclusion chapter and 11 units, each consisting of an introductory essay, submission checklist, evaluation checklist giving guidance on FDA criteria, and.
Book details
- Year
- 2009
- Language
- English
- Publisher
- John Wiley
- Editions
- 1
- Pages
- 379
- ISBN
- 9780470371381
Data source: Wikidata
