FDA's Drug Review Process and the Package Label provides a guide to pharmaceutical companies for writing FDA-submissions. This book covers all essential elements in FDA-approval including Clinical Study Reports, Investigator's Brochures, and the Common Technical Document (eCTD). Specifically, the book provides guidance to medical writers in the pharmaceutical industry for drafting FDA-submissions that will persuade FDA reviewers to grant approval to the drug. Containing excerpts copied from various package labels to demonstrate how the Sponsor's arguments, together with feedback,...
FDA's Drug Review Process and the Package Label provides a guide to pharmaceutical companies for writing FDA-submissions. This book covers a...
