FDA's Gastro Drug Fast-Track Denial Survives DC Circ.

By Ali Sullivan · December 18, 2024, 8:59 PM EST

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...

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Documents

Case Information

Case Title

Vanda Pharmaceuticals, Inc. v. FDA, et al

Case Number

23-5200

Court

Appellate - DC Circuit

Nature of Suit

2899 Other Statutes APA/Review Agency

Date Filed

September 11, 2023