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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U.S. Generic User Fees Might Combine Inspection Visits, Boost Foreign Cooperation
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
Generic User Fees Might Combine Inspection Visits, Boost Foreign Cooperation
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.