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Mifepristone Manufacturer Wins First Round in West Virginia

Drug & Device Law

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. The potential customers were subject to a “credible threat” of prosecution.

FDA 111
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Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

2001) (no causation where medical personnel “had no alternative other than to use the. . . 2007 WL 2526402, at *3 (D. 2007 WL 5861354, at *4 (C.D. 2007 WL 5861354, at *4 (C.D. 19, 2007) (unpublished); In re Accutane Litigation , 2016 WL 355843, at *13-17 (N.J. 2007 WL 4218982, at *1 n.1 756 (9th Cir.

FDA 59