Appeals court reverses district court’s stay of FDA’s approval of the medication abortion pill but pauses all agency actions taken since 2016, including changes to REMS and approval of GenBioPro’s generic mifepristone. DOJ and Danco are appealing to the Supreme Court on Friday.
The US Food and Drug Administration’s approval of mifepristone remains in effect but the US Court of Appeals for the Fifth Circuit let stand a district court’s stay of all agency actions taken since it modified the Risk Evaluation and Mitigation Strategy for the medication abortion drug in 2016.
That means that unless the decision is reversed patients will no longer be able to obtain mifepristone by mail or...
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.
As Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency.
Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.
