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Latest From Michael Cipriano
Agency to discuss results of report, as well as pending 2018 pilot project designed to modernize its hiring practices.
Generic association advocates enforcement action against companies that use REMS to block generics while PhRMA disputes claims of REMS abuse and citizen petition delay tactics.
Other proposals were broad in nature, and did not provide the agency with specific mechanisms to consider.
The latest drug approval and development news from our US FDA Performance Tracker.
US FDA's approval of Ultragenyx's Mepsevii (vestronidase alfa-vjbk) marks first novel biologic with a suffix, but 10 months after release of the naming guidance how – and even how widely – FDA will implement the policy remains uncertain.
US FDA might approve Indivior and Braeburn's injectable buprenorphine products simultaneously; here's a side-by-side look at the advantages and disadvantages of each.