FDA looks to prepare reviewers for complex submissions
This article was originally published in The Gold Sheet
Executive Summary
The Office of Pharmaceutical Science in FDA's Center for Drug Evaluation and Research is looking to prepare its reviewers for increasingly challenging drug applications as the agency begins to see the submission of novel and complex dosage forms. The office is seeking to find organizations that could deliver a professional development program "to ensure reviewers are current in state-of-the-art pharmaceutical manufacturing and technology," the agency said in a June 2 sources sought notice