In Brief: FDA user fee cover sheet
This article was originally published in The Tan Sheet
Executive Summary
FDA user fee cover sheet: Agency opens 60-day public comment period on Form 3397, cover sheets designed to collect information to help the agency determine whether it should require a user fee for a specific drug or biologic application and the fee amount. FDA estimates in the Nov. 12 Federal Register that 200 manufacturers are subject to user fees, including 141 Center for Drug Evaluation & Research applicants...