Bullseye On OTC Reproductive Drug Approvals In US After Federal Judge Questions FDA Expertise?
Attorneys comment to HBW about likelihoods of litigation to challenge FDA’s approval of OTC emergency contraceptive and of influence growing to affect agency’s consideration of NDA for OTC daily oral contraceptive.
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Tobacco rules limiting nicotine and banning menthol in cigarettes also would be defunded in the bill.
Agency appeals Texas federal court decision staying its approval of the medication abortion pill. It is unclear how the ruling would be implemented if it stands, and what the impact might be from an opposing same-day order from another court for FDA to keep mifepristone available. Texas ruling could have significant consequences for industry, former FDA attorney says.
After postponing planned November advisory committees’ meeting to have time to review more information it requested from sponsor HRA Pharma, FDA sets meeting for 9-10 May. Expanding meeting from one day to a day and a half should allow considering all views and questions about contraceptives.