September 11, 2023
Vanda Pharmaceuticals, Inc. v. FDA, et al
Case Number:
23-5200
Court:
Nature of Suit:
2899 Other Statutes APA/Review Agency
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Reflects complaints, answers, motions, orders and trial notes entered from Jan. 1, 2011.
Additional or older documents may be available in Pacer.
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December 18, 2024
FDA's Gastro Drug Fast-Track Denial Survives DC Circ.
A D.C. Circuit panel upheld federal regulators' refusal to streamline approval of a drug to treat nausea in patients with a chronic gastric condition, ruling that the U.S. Food and Drug Administration was right to consider the drug's development plan when deciding whether it qualified for fast tracking.
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