21 C.F.R. §10.45 - Court review of final administrative action; exhaustion of administrative remedies

Cite as21 C.F.R. §10.45
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57 cases
  • Mylan Pharmaceuticals Inc. v. Henney, Civil Action No. 99-cv-862(RMU).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • March 31, 2000
    ...566 A.2d 483, 485 (D.C. 1989)). The FDA defines "administrative exhaustion" for purposes of invoking judicial relief as follows. Under 21 C.F.R. § 10.45, the Commissioner's final decision constitutes final agency action subject to judicial review "on a petition for stay of action" submitted......
  • Heckler v. Chaney
    • United States
    • United States Supreme Court
    • March 20, 1985
    ...In addition, if read to circumscribe agency enforcement discretion, the statement conflicts with the agency rule on judicial review, 21 CFR § 10.45(d)(2) (1984), which states that "[t]he Commissioner shall object to judicial review . . . if (i) [t]he matter is committed by law to the discre......
  • Stauber v. Shalala, 94-C-0090-C.
    • United States
    • United States District Courts. 7th Circuit. Western District of Wisconsin
    • August 4, 1995
    ......94-C-0090-C. . United States District Court, W.D. Wisconsin. . August 4, 1995. 895 F. Supp. ....         This is a civil action for declaratory and injunctive relief brought suant to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-394, the National Environmental ...§§ 4321-4370d, and the Administrative Procedure Act, 5 U.S.C. §§ 500-706. Plaintiffs ...After a close review of the parties' submissions, I find that ....          B. Exhaustion .         Defendants contend that ... failed to exhaust their administrative remedies with respect to their labeling claim. Under FDA ... on new drug applications constitute final agency action for purposes of exhaustion. 21 ......
  • Teva Pharm. USA, Inc. v. U.S. Food & Drug Admin.
    • United States
    • United States District Courts. United States District Court (Columbia)
    • December 31, 2020
    ...decision based on a [Citizen Petition] ... before any legal action is filed in a court complaining of the action or failure to act[.]" 21 C.F.R. § 10.45(b). Teva did not contend that Copaxone was analogous to a vaccine in any of the eight Citizen Petitions it filed. It now claims that inclu......
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