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Latest From Approvals
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.
The latest drug development news and highlights from our FDA Performance Tracker.
Original new drugs and biologics recently approved by US FDA.
US generic drug approvals and tentative approvals for mid-February.
Sandoz/Momenta’s generic of Teva’s 40 mg Copaxone appeared imminent – until apparently unrelated FDA warning letter regarding contract manufacturer Pfizer’s McPherson, Kan., plant put review on hold.
New molecular entities and novel biologics on US FDA's user fee calendar for 2017.
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