Citizen Petition definition

Citizen Petition means a public request that the FDA issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action pursuant to 21 C.F.R. § 10.30.
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Citizen Petition means a petition filed with the FDA pursuant to 21 C.F.R. § 10.
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Examples of Citizen Petition in a sentence

  • Further, at no time ▇▇▇▇ ▇▇▇▇▇▇ or its Affiliates bring or cause others to bring suit against Endo/Teikoku regarding or relating in any way to Citizen Petition Docket No. FDA-2006-P-0346-0006.

  • The Citizen Petition is currently under review by FDA and the company continues to believe in the merits of the arguments set forth in the CP.

  • Nothing in this provision shall prohibit Endo/Teikoku or their respective Affiliates from responding to questions from FDA or a Third Party regarding Citizen Petition Docket No. FDA-2006-P-0346-0006; taking any action, or causing others to take any action, required, requested or recommended by the FDA or other governmental authority; intervening in any lawsuit relating to the Brand Product or any Generic Product; or taking any action, or causing others to take any action as required by Applicable Law.

  • Citizen Petition to the U.S. Department of Education on Title IV Arbitration Clauses.

  • In December 2006, Endo filed a Citizen Petition (CP) with FDA raising questions about whether FDA’s proposed approval requirements for generic Lidoderm were sufficient to determine bioequivalence.

  • Par agrees that the Citizen Petition filed by Somaxon with the FDA on October 20, 2011 is deemed to be “outside of Plaintiff’s control” for purposes of this Section 5.4; however, any other petition, request, demand or similar filing by or on behalf of Plaintiffs with any court, agency or administrative body relating to the Silenor Products insofar as such a filing affects FDA approval of Par Generic Products is not “outside of Plaintiff’s control” for purposes of this Section 5.4.

  • Cephalon agrees not to file or cause to be filed a Citizen Petition with the FDA challenging: the marketing approval of ACTIQ Licensed Product, or ACTIQ SF Licensed Product.