Abuse Deterrence: US Exclusivity Update May Ride User Fee Coattails
CDER's Woodcock suggests exclusivity rules outdated for abuse-deterrent technology development, and Rep. Griffith takes it to mean legal changes are needed.
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Having sat on the sidelines during the unsuccessful effort to repeal and replace Obamacare, the pharma industry may find the rest of its legislative agenda, from taxes to even user fee reauthorization, could become more difficult.
Sen. Burr asks FDA whether fee revenue should be rebated for not meeting some PDUFA V goals.
Inspirion’s MorphaBond win suggests agency’s thinking on three-year exclusivity for abuse-deterrent formulations has ‘evolved’ from a formulation-specific approach to one based on route of abuse.