Generics Clash With FDA Over GDUFA II Priority Review Provisions

November 16, 2017 at 9:05 PM
Generic stakeholders are clashing with FDA over what most thought were completed Generic Drug User Fee Amendments (GDUFA II) negotiations, namely the steps sponsors must take to be eligible for priority review. While the head of FDA's Office of Generic Drugs recently said any suggestions to improve GDUFA II must be held until the next round of GDUFA, the parties are clashing over FDA's guidance around the GDUFA II commitment letter, interpretations which the Association for Accessible Medicines believes run...

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