21 C.F.R. §10.25 - Initiation of administrative proceedings

Cite as21 C.F.R. §10.25
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97 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......
  • Ass'n of Am. Physicians v. Food & Drug Admin.
    • United States
    • United States District Courts. United States District Court (Columbia)
    • March 4, 2008
    ...the FDA provides an avenue for plaintiffs to achieve the labeling changes they desire. Plaintiffs may file a citizen petition under 21 C.F.R. §§ 10.25, 10.30, The Court therefore concludes that plaintiffs' alleged informational injuries are inadequate to support constitutional standing B. I......
  • Medinatura, Inc. v. Food & Drug Admin., Civil Action No. 20-2066 (RDM)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • October 23, 2020
    ...Dkt. 15 at 26 n.6.3 Drug manufacturers or others can request administrative action from the FDA through a citizen petition process. See 21 C.F.R. §§ 10.25, 10.30. Any "interested person" may petition the FDA to "issue, amend, or revoke a regulation or order, or to take or refrain from takin......
  • In re Epipen
    • United States
    • United States District Courts. 10th Circuit. United States District Courts. 10th Circuit. District of Kansas
    • June 23, 2021
    ...it "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(a).22 Again, plaintiffs object to this exhibit as inadmissible hearsay to which no exception applies. Doc. 2190-1 at 77. Defendants respond tha......
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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......

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