The landmark litigation attempting to remove mifepristone from the market involves issues central to the US Food and Drug Administration’s regulation of drug products. The outcome will impact who is able to file suit to seek reversal of a drug approval and whether courts can set aside the agency’s evaluation of scientific data.
Breaking Down The Arguments In The Mifepristone Case
Chart encapsulates the fundamental questions in Alliance for Hippocratic Medicine v. FDA and the arguments of both parties on standing to sue, the agency’s approval standards, REMS changes, and the Comstock Act of 1873.
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