Nothing left to be said? FDA explains generic user fees
This article was originally published in Scrip
Executive Summary
All appeared copasetic at a 19 December public meeting convened by the US FDA to give industry and the public an opportunity to provide input or reaction to a proposed plan in which generic drug makers for the first time will pay fees in the US to help cover the costs of reviews of abbreviated new drug applications (ANDAs), plant inspections and other regulatory activities, in exchange for certain goal requirements from the agency.