21 C.F.R. §10.30 - Citizen petition

Cite as21 C.F.R. §10.30
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160 cases
  • Neurelis, Inc. v. Aquestive Therapeutics, Inc.
    • United States
    • California Court of Appeals
    • 17 d3 Novembro d3 2021
    ...this petition process, the FDA permits private entities to provide comments and opinions on draft guidance by filing these petitions.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......
  • 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
    • 21 d2 Agosto d2 2018
    ..."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 ......
  • Ass'n of Am. Physicians v. Food & Drug Admin., Civil Action No. 07-0668 (JDB).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • 4 d2 Março d2 2008
    ...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 ......
  • Little v. Purdue Pharma, L.P., Case No. C-3-01-344.
    • United States
    • United States District Courts. 6th Circuit. United States District Courts. 6th Circuit. Southern District of Ohio
    • 20 d5 Setembro d5 2002
    ...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
  • Antitrust
    • United States
    • ABA General Library ANDA litigation: strategies and tactics for pharmaceutical patent litigators
    • 2 d4 Junho d4 2016
    ...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......
  • Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety
    • United States
    • Iowa Law Review No. 99-1, November 2013
    • 1 d5 Novembro d5 2013
    ...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......
  • Antitrust Analysis of Pharmaceutical Manufacturer Conduct
    • United States
    • ABA Antitrust Library Pharmaceutical Industry Antitrust Handbook. Second Edition
    • 8 d6 Dezembro d6 2018
    ...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......
  • Trial
    • United States
    • ABA Antitrust Library Indirect Purchaser Litigation Handbook. Second Edition
    • 5 d1 Dezembro d1 2016
    ...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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