21 C.F.R. §10.30 - Citizen petition
| Cite as | 21 C.F.R. §10.30 |
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160 cases
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Neurelis, Inc. v. Aquestive Therapeutics, Inc.
...this petition process, the FDA permits private entities to provide comments and opinions on draft guidance by filing these petitions. ( 21 C.F.R. § 10.30 (2021).) A petition can request that the FDA "issue, amend, or revoke a regulation or order or take or refrain from taking any other form......
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In re Lipitor Antitrust Litig., Civil Action No. 3:12-cv-2389 (PGS)(DEA)
..."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 merits of the sham ......
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Ass'n of Am. Physicians v. Food & Drug Admin., Civil Action No. 07-0668 (JDB).
...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. Increased Risk of ......
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Little v. Purdue Pharma, L.P., Case No. C-3-01-344.
...would be more inclined to view the cause of action as encompassing nothing more than that which the administrative action provides. See 21 C.F.R. § 10.30 (2001)(providing for "citizen Page 860 to contest FDA actions).27 That, though, is not what Plaintiffs seek. (See supra note 5.) Any fede......
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6 books & journal articles
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Antitrust
...not delay approval of a pending ANDA or 505(b)(2) application as a result of a citizen petition submitted to the agency pursuant to 21 C.F.R. § 10.30 (citizen petition) or § 10.35 (petition for stay of action), unless FDA “determines, upon reviewing the petition, that a delay is necessary t......
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Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety
...USA TODAY (Oct. 4, 2004, 12:09 AM), http://usatoday30. usatoday.com/money/industries/health/drugs/2004-10-04-vioxx-insurers_x.htm. 226. 21 C.F.R. § 10.30 (2012). 227 . Id. § 10.30(b). 228 . An ANDA is an application from a generics company to the FDA to approve a generic drug product. After......
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Antitrust Analysis of Pharmaceutical Manufacturer Conduct
...Lawyer Says,” Reuters (Jan. 22, 2016), available at http://www.reuters.com/article/us-usa-crime-shkreliidUSKCN0V026V. 300. See 21 C.F.R. § 10.30. taking any form of administrative action within the FDA’s jurisdiction. 301 The petition is public and open to comment, and the FDA’s response to......
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Trial
...experts for lack of adequate credentials. 78 For example, experts who lacked sufficient experience taking an administrative action. See 21 C.F.R. § 10.30. In In re Flonase, the citizen petitions requested that the Commissioner refrain from approving defendant’s generic drug. 884 F. Supp. 2d......
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