21 C.F.R. §10.25 - Initiation of administrative proceedings
| Cite as | 21 C.F.R. §10.25 |
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97 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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Ass'n of Am. Physicians v. Food & Drug Admin.
...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......
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Medinatura, Inc. v. Food & Drug Admin., Civil Action No. 20-2066 (RDM)
...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......
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In re Epipen
...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
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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......