21 C.F.R. § 12.140
Review by the courts
(a) The Commissioner's final decision constitutes final agency action from which a participant may petition for judicial review under the statutes governing the matter involved. Before requesting an order from a court for a stay of action pending review, a participant shall first submit a petition for a stay of action under § 10.35.
(b) Under 28 U.S.C. 2112(a), FDA will request consolidation of all petitions related to a particular matter.
Notes of Decisions
Cited in 2
cases (1 in the last 5 years), 1980–2024 · leading case: Se. Minerals, Inc. & Marshall Minerals, Inc. v. Patricia Roberts Harris, as Sec'y of Health & Human Servs., 622 F.2d 758 (5th Cir. 1980).
Se. Minerals, Inc. & Marshall Minerals, Inc. v. Patricia Roberts Harris, as Sec'y of Health & Human Servs., 622 F.2d 758 (5th Cir. 1980). “§ 348 (g); 21 C.F.R. §§ 12.140 to 12.159 (1978). 8 .”
In re: Merck Mumps Vaccine Antitrust Litig. v. (3rd Cir. 2024). “§ 1001 ; and (5) the threatened actions in the FDA’s Warning Letter would have been subject to judicial review, see 21 C.F.R. § 12.140 (procedures for judicial review of the FDA Commissioner’s final decisions).”
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