Cases citing 21 C.F.R. §§ 316.3

Berlex Laboratories, Inc. v. Food & Drug Administration

Oct. 7, 1996

942 F. Supp. 19 · United States District Court for the District of Columbia · United States
Baker Norton Pharmaceuticals, Inc. v. United States Food & Drug Administration

Feb. 6, 2001

132 F. Supp. 2d 30 · United States District Court for the District of Columbia · United States
Sigma-Tau Pharmaceuticals, Inc. v. Schwetz

May 2, 2002

288 F.3d 141 · United States Court of Appeals for the Fourth Circuit · United States
Mutual Pharmaceutical Co. v. Iyax Pharmaceuticals, Inc.

Oct. 17, 2006

459 F. Supp. 2d 925 · United States District Court for the Central District of California · United States
Depomed, Inc. v. United States Department of Health & Human Services

Sept. 5, 2014

66 F. Supp. 3d 217 · United States District Court for the District of Columbia · United States
Spectrum Pharmaceuticals, Inc. v. Burwell

June 3, 2016

824 F.3d 1062 · United States Court of Appeals for the District of Columbia Circuit · United States
Spectrum Pharmaceuticals, Inc. v. Burwell

June 3, 2016

423 U.S. App. D.C. 51, 824 F.3d 1062 · United States Court of Appeals for the District of Columbia Circuit · United States
Braeburn Inc. v. U.S. Food & Drug Admin.

July 22, 2019

389 F. Supp. 3d 1 · United States Court of Appeals for the District of Columbia · United States