Ebook: FDA’s drug review process and the package label : strategies for writing successful FDA submissions
Author: Brody Tom
- Tags: United States -- Food and Drug Administration, Drug approval -- Government policy -- United States, Clinical trials -- United States -- Moral and ethical conflicts, Drug approval -- Safety regulations -- United States, United States
- Year: 2018
- Publisher: Academic Press
- City: United States.
- Language: English
- epub
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 Read more...