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

 
• By Sue Sutter

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.

A realistic literal depiction of the saying get a foot in the door - 3D render
IPEC-Americas is trying to get a foot in the door to industry's negotiations with the FDA on GDUFA III. • Source: Shutterstock

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