Generic User Fees: FDA Reaches Out To More Trade Groups; Plan Could Mix Inspection and Application Fees
FDA continues to mull inspection- and application-based proposals for a generic drug user fee, but before beginning negotiations it wants comments from a wider breadth of the industry.
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Generic User Fee Agreement Includes FDA Pledge To Determine Best Use Of Foreign Regulator Inspections
Draft commitment letter could be first step down globalization road in which FDA relies more on foreign governments to boost manufacturing oversight.
U.S. FDA and the generic industry are considering ideas for combining inspections to reduce the number of visits from regulators as part of user fee discussions, while industry is concerned changes could affect cooperation with foreign entities
Agency outlines ideas for coordinating and combining different types of facility inspections in generic drug user fee negotiations, while industry asks how it will affect collaboration with international regulators.