21 CFR 10.25 - Initiation of administrative proceedings

Cite as21 CFR 10.25
    • This document is available in original version only for vLex customers

      View this document and try vLex for 7 days
    • TRY VLEX
166 practice notes
  • In re Wellbutrin XL Antitrust Litig. Indirect Purchaser Class, Nos. 15-2875
    • United States
    • United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
    • August 9, 2017
    ...the FDA] to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action." 21 C.F.R. § 10.25. GSK elected not to join Biovail's FDA petition.12 Abrika settled with Biovail a few months later, after GSK had withdrawn from the suit.1......
  • Abigail Alliance for Better Access v. Von Eschenbach, No. 04-5350.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • August 7, 2007
    ...ill members, the Alliance submitted its own proposals to the FDA. Those proposals culminated in a "citizen petition" to the FDA, see 21 C.F.R. § 10.25, arguing that there is a "different risk-benefit tradeoff facing patients who are terminally ill and who have no other treatment options." A......
  • Caretolive v. Von Eschenbach, No. 2:07-cv-729.
    • United States
    • United States District Courts. 6th Circuit. United States District Courts. 6th Circuit. Southern District of Ohio
    • December 4, 2007
    ...is the mechanism for formally asking the agency to take a particular action, and is a prerequisite to filing suit on the subject. See 21 C.F.R. §§ 10.25, 10.30, 10.45. In its citizen petition, Plaintiff urges the Commissioner of the FDA to "reverse [the FDA's] decision to deny immediate app......
  • In re Lipitor Antitrust Litig., Civil Action No. 3:12-cv-2389 (PGS)(DEA)
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • August 21, 2018
    ...the agency to "issue, amend, or revoke a regulation or order, or take or refrain from taking any other forms of administrative action." 21 C.F.R. §§ 10.25, 10.30. Here, Defendants make a similar "but for" argument as discussed above in Wellbutrin and contend that before addressing the merit......
  • Request a trial to view additional results
91 cases
  • In re Lipitor Antitrust Litig., Civil Action No. 3:12-cv-2389 (PGS)(DEA)
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • August 21, 2018
    ...the agency to "issue, amend, or revoke a regulation or order, or take or refrain from taking any other forms of administrative action." 21 C.F.R. §§ 10.25, 10.30. Here, Defendants make a similar "but for" argument as discussed above in Wellbutrin and contend that before addressing the merit......
  • Indep. Turtle Farmers Of La. Inc v. U.S.A, Civil Action No. 1:07-cv-00856.
    • United States
    • U.S. District Court — Western District of Louisiana
    • March 30, 2010
    ...872 (5th Cir.2006). Moreover, remand is one of the remedies explicitly contemplated by the FDA's procedural regulations as well. See 21 C.F.R. § 10.25(b) (“FDA ... will request a court to dismiss, or to hold in abeyance its determination of or refer to the agency for administrative determin......
  • Reckis v. Johnson & Johnson, SJC–11677.
    • United States
    • United States State Supreme Judicial Court of Massachusetts
    • April 17, 2015
    ...that it “issue, amend, or revoke a regulation or order, or ... take or refrain from taking any other form of administrative action.” 21 C.F.R. § 10.25(a)(2) (1989). See In re Prograf Antitrust Litig., U.S. Dist. Ct., No. 1:11–md–2242–RWZ, 2012 WL 293850 (D.Mass. Feb. 1, 2012).15 The citizen......
  • ViroPharma, Inc. v. Hamburg, Civil Action No. 12–0584 (ESH).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • April 23, 2012
    ...with the FDA. See AstraZeneca Pharm., 850 F.Supp.2d at 235–36;Biovail Corp. v. FDA, 448 F.Supp.2d 154, 157 n. 2 (D.D.C.2006); 21 C.F.R. §§ 10.25(a), 10.30(e). 12. After ViroPharma's sNDA was approved on December 14, 2011, ViroPharma filed another supplement to its Citizen Petition requestin......
  • Request a trial to view additional results
2 firm's commentaries
  • The FDA’s “Natural” Reluctance: What it Means for Class Action Lawsuits
    • United States
    • JD Supra United States
    • April 25, 2014
    ...FDA rules.[1] Faced with these class actions, several federal judges reached out to the FDA for an administrative determination under 21 C.F.R. § 10.25(c), asking whether manufacturers can label food products containing bioengineered ingredients as “natural” or “all natural” or “100% natura......
  • When More Is Neither Better Nor a Lawsuit
    • United States
    • LexBlog United States
    • December 5, 2014
    ...or which, if previously determined, the agency concluded should be reconsidered and subject to a new administrative determination. 21 C.F.R. § 10.25. Since the FDA is in the midst of considering (admittedly, slowly) whether SPF values greater than 50 provide any additional benefit, the cour......

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT