Fda's Drug Review Process and the Package Label: Strategies for Writing Successful FDA Submissions

by Tom Brody

FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions...

• Format: Paperback
• Language: English
• ISBN: 0128146478
• ISBN13: 9780128146477
• Release Date: December 2017
• Publisher: Academic Press
• Length: 670 Pages