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

  • Indeed, from the very beginning, FDA staff acknowledged that the Plan B sponsor would work with the FDA to address any concerns raised by the Citizen Petition.

  • Moreover, no meaningful review of the denial of the Citizen Petition would be possible without a review of the administrative record for the SNDAs because the FDA understood the issues presented by the SNDAs and Citizen Petition to be one and the same.

  • It also alleges that Mylan waited until May 2015—almost five months after filing its Citizen Petition and only weeks before the FDA was required to respond—to supplement its Petition with a 48-page independent study purportedly showing that patients would not use Teva’s generic product correctly.

  • Next, the Mylan Defendants argue that the class plaintiffs’ allegations about the FDA Citizen Petition fail to state a plausible antitrust claim.

  • The Mylan Defendants explain that a federal statute requires the FDA to take final agency action on a Citizen Petition within 150 days (about five months).

  • For the same reasons, the court finds that the class plaintiffs plausibly have alleged that Mylan’s Citizen Petition delayed the FDA approval process.11Second, the Mylan Defendants assert that the Noerr-Pennington doctrine bars the class plaintiffs’ claims based on the FDA Citizen Petition.

  • The Mylan Defendants assert two arguments supporting dismissal.First, the Mylan Defendants contend, the Class Complaint never alleges that the Citizen Petition caused any delay in the FDA approval process.

  • The Class Complaint quotes a legal scholar who has questioned the timing of Mylan’s Citizen Petition and suggested that it was part of a strategy to delay Teva’s ANDA approval.

  • Indeed, in February 2001, shortly before the Citizen Petition had been filed, FDA staff met with the Plan B sponsor to discuss a development plan for an over-the-counter switch application, including the details for a proposed actual use study and label comprehension study.

  • And, 21 U.S.C. § 355(q)(1)(A) provides that theSecretary “shall not delay approval” of a pending ANDA based on the filing of a Citizen Petition.

Related to Citizen Petition

  • Post-Petition means the time period beginning immediately upon the filing of the Chapter 11 Cases.

  • Debtor Laws means all applicable liquidation, conservatorship, bankruptcy, moratorium, arrangement, receivership, insolvency, reorganization, or similar laws, or general equitable principles from time to time in effect affecting the rights of creditors generally.

  • primary insolvency jurisdiction means the Contracting State in which the centre of the debtor’s main interests is situated, which for this purpose shall be deemed to be the place of the debtor’s statutory seat or, if there is none, the place where the debtor is incorporated or formed, unless proved otherwise;

  • insolvency practitioner means any receiver, administrator or liquidator appointed in respect of the Tenant;

  • Competition Laws means statutes, rules, regulations, orders, decrees, administrative and judicial doctrines, and other laws that are designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization, lessening of competition or restraint of trade.

  • Competition Act means the Competition Act (Canada).

  • High Court means the High Court of Ireland;

  • Post-Petition Interest means any interest or entitlement to fees or expenses or other charges that accrues after the commencement of any Insolvency Proceeding, whether or not allowed or allowable in any such Insolvency Proceeding.

  • foreign proceeding means a collective judicial or administrative proceeding in a foreign State, including an interim proceeding, pursuant to a law relating to insolvency in which proceeding the assets and affairs of the debtor are subject to control or supervision by a foreign court, for the purpose of reorganization or liquidation;

  • CCAA means the Companies’ Creditors Arrangement Act (Canada).

  • Insolvency Act means the Insolvency Act, 1936 (Act No. 24 of 1936);

  • Bankruptcy Act means the Bankruptcy Act or Title 11 of the United States Code.

  • Bankruptcy Proceedings has the meaning set forth in clause (b) of paragraph 9 hereof.

  • Bankruptcy Proceeding means any case, action or proceeding before any court or other Governmental Authority relating to any Bankruptcy Event.

  • Insolvency Proceedings means, with respect to any Person, any case or proceeding with respect to such Person under U.S. federal bankruptcy laws or any other state, federal or foreign bankruptcy, insolvency, reorganization, liquidation, receivership or other similar laws, or the appointment, whether at common law, in equity or otherwise, of any trustee, custodian, receiver, liquidator or the like for all or any material portion of the property of such Person.

  • Insolvency or Liquidation Proceeding means, with respect to any Person, any liquidation, dissolution or winding up of such Person, or any bankruptcy, reorganization, insolvency, receivership or similar proceeding with respect to such Person, whether voluntary or involuntary.

  • Special Purpose Bankruptcy Remote Entity shall have the meaning set forth on Schedule 5 hereto.

  • Relief means any relief, loss, allowance, credit, exemption, deduction or set off, or any right to repayment of Taxation;

  • Defendant/Person Under Supervision means any pretrial releasee, probationer, parolee, mandatory releasee, mandatory parolee, or supervised releasee receiving drug/alcohol testing and/or substance use assessment/treatment, mental health assessment/evaluation/treatment, and or sex offense specific evaluation/treatment/testing while under the supervision of the Federal Probation or Pretrial Services Office. Hereinafter, the term defendant applies to those on pretrial supervision, whereas person under supervision applies to those on post- conviction supervision.

  • Competition Act Approval means that the Commissioner: (a) shall have issued an ARC, or (b) the applicable waiting period under section 123 of the Competition Act shall have expired or been terminated by the Commissioner, or the obligation to submit a notification shall have been waived under paragraph 113(c) of the Competition Act, and the Commissioner shall have issued a No-Action Letter;

  • Pre-Petition Credit Agreement has the meaning assigned to such term in the Recitals.

  • Insolvency Action With respect to any Person, the taking by such Person of any action resulting in an Insolvency Event, other than solely under clause (g) of the definition thereof.

  • Competition Law means any Law that is designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization or lessening of competition through merger or acquisition or restraint of trade.

  • Chapter 11 means Chapter 11 of the Bankruptcy Code.

  • Applicable Insolvency Laws means all Applicable Laws governing bankruptcy, reorganization, arrangement, adjustment of debts, relief of debtors, dissolution, insolvency, fraudulent transfers or conveyances or other similar laws (including, without limitation, 11 U.S.C. Sections 544, 547, 548 and 550 and other “avoidance” provisions of Title 11 of the United States Code, as amended or supplemented).

  • Insolvency Laws The Bankruptcy Code and all other applicable liquidation, conservatorship, bankruptcy, moratorium, rearrangement, receivership, insolvency, reorganization, suspension of payments, or similar debtor relief laws from time to time in effect affecting the rights of creditors generally.