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GDUFA II Negotiations: Contract Manufacturers Gain Seat At Table

Executive Summary

Generic user fees could be segmented further by addition of new group.

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Excipients Group Seeks Seat At GDUFA Negotiating Table

IPEC-Americas requests an improved communications channel with the FDA and formal inclusion in talks to reauthorize the generic drug user fee program; agency says industry negotiators generally represent product manufacturers and API suppliers that are subject to user fees.

GDUFA III: Excipients Group Seeks Seat At Negotiating Table, But US FDA Skeptical

IPEC-Americas requests an improved communications channel with the FDA and formal inclusion in talks to reauthorize the generic drug user fee program; agency says industry negotiators generally represent product manufacturers and API suppliers that are subject to user fees.

Generic User Fee Renewal Talks Faced 'Buyer's Remorse' From GDUFA I

Industry dismay at slow pace of ANDA approvals and FDA communications in early years of first user fee agreement factored into GDUFA II negotiations.

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