US GDUFA III Talks In Final Stages, Agreement Nearly Complete

Final commitment letter preparations now under way as revenue issues are resolved.

Hands reaching out to each other.
Industry and FDA representatives agreed that any remaining GDUFA III sessions will be scheduled as needed. • Source: Alamy

US Generic drug user fee reauthorization negotiations are close to completion after nearly 11 months, with the ratification and Capitol Hill phases of the process upcoming.

Minutes of a 29 July meeting indicated that industry and US Food and Drug Administration officials discussed the draft...

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