GDUFA IV

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11
Aug

OGD GDUFA IV Proposed Commitment Letter Available for Comment

By    Aug 11, 2026    ANDAs GDUFA IV Generics OGD Regulatory Affairs

After months of negotiations, the FDA published a proposed Commitment Letter for GDUFA IV, which will outline the OGD and Industry’s agreements regarding all aspects of the ANDA review and approval process. The proposed commitment letter can be found here. The 48-page document addresses all issues that have undergone negotiations regarding the proposed new iteration […]

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23
Mar
GDUFA IV Negotiation Session Minutes

GDUFA IV Negotiation Session Minutes

By    Mar 23, 2026    ANDAs GDUFA IV Regulatory Affairs

The ongoing GDUFA IV negotiations have shed some light on interesting issues that will apply to the new GDUFA reauthorization period for FYs 2028 to 2032 presently being considered by both industry and the FDA.  The full minutes of the February 19, 2026 FDA-industry negotiation meeting can be found here, but I have a brief summary of the […]

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