Mifepristone Manufacturer Wins First Round in West Virginia
Drug & Device Law
MAY 19, 2023
In 2007 (during the Bush Administration), Congress amended the FDCA to provide for Risk Evaluation and Mitigation Strategy (“REMS”), “to assure safe use,” which the FDA applied to mifepristone. [T]he Sorsaia , 2023 WL 3211847, at *7 (citations omitted). See also GenBioPro, Inc. Sorsaia , C.A. 2023 WL 3451688, at *1 (S.D.W.
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