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Generic User Fees: API Manufacturers To Pay Less Than Finished Dose Firms

Executive Summary

FDA and industry have agreed to create separate tiers for the charges that active pharmaceutical ingredient manufacturers and finished dosage form manufacturers will pay as part of a generic drug user fee program.

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Generic Drug User Fees Will Begin With The Backlog

FDA set aside fears that a separate fee for the application backlog would create administrative problems for its generic drug user fee program, instead choosing to use the queue of pending submissions to help gain more funding at launch.

Generic Drug User Fees Will Begin With The Backlog

FDA set aside fears that a separate fee for the application backlog would create administrative problems for its generic drug user fee program, instead choosing to use the queue of pending submissions to help gain more funding at launch.

FDA, Industry Reach Agreement On Major Portions Of Generic User Fee Program

Pending agreement includes a one-time fee for ANDA applications in the backlog.

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