Judge:  FDA Didn't Violate Procedure In Approving 'Same' Orphan Drug Twice

(August 4, 2020, 11:05 AM EDT) -- MIAMI — A Florida federal judge on July 30 granted summary judgment against a drug company that claimed that the federal government violated the Administrative Procedure Act in approving the "same drug" for which the plaintiff had received orphan drug exclusivity (Catalyst Pharmaceuticals, Inc. v. Alex Azar, et al., No. 19-22425, S.D. Fla.)....

Attached Documents

Related Sections