Title: Guidebook for drug regulatory submissions
First published: 2009
Description: 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.
Subjects: Drug Approval, Drugs, Drugs, Investigational, Investigational Drugs, Law and legislation, Drugs, law and legislation, Pharmaceutical policy
Places: United States
LC classification: KF3885 W45 2009