21 CFR 10.25 - Initiation of administrative proceedings
| Cite as | 21 CFR 10.25 |
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166 practice notes
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In re Wellbutrin XL Antitrust Litig. Indirect Purchaser Class, Nos. 15-2875
...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 GSK elected not to join Biovail's FDA petition.12 Abrika settled with Biovail a few months later, after GSK had withdrawn from the suit.1......
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Abigail Alliance for Better Access v. Von Eschenbach, No. 04-5350.
...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......
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Caretolive v. Von Eschenbach, No. 2:07-cv-729.
...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......
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In re Lipitor Antitrust Litig., Civil Action No. 3:12-cv-2389 (PGS)(DEA)
...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......
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91 cases
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In re Lipitor Antitrust Litig., Civil Action No. 3:12-cv-2389 (PGS)(DEA)
...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......
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Indep. Turtle Farmers Of La. Inc v. U.S.A, Civil Action No. 1:07-cv-00856.
...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......
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Reckis v. Johnson & Johnson, SJC–11677.
...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......
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ViroPharma, Inc. v. Hamburg, Civil Action No. 12–0584 (ESH).
...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......
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2 firm's commentaries
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The FDA’s “Natural” Reluctance: What it Means for Class Action Lawsuits
...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......
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When More Is Neither Better Nor a Lawsuit
...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......