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

  • In its denial of GSK’s 2019 citizen petition, the FDA detailed its “approach to the review of [safety-related] information in the context of relevant statutory and regulatory requirements.” (Notice by Plaintiffs’ Lead Counsel of FDA Denial of GSK’s Citizen Petition, January 15, 2021, Ex. A at 2).

  • The FDA specifically stated in its denial of GSK’s citizen petition that it continued to “monitor and review available safety information related to” Zofran and that it would “take further action” if it deemed it “appropriate.” (Notice by Plaintiffs’ Lead Counsel of FDA Denial of GSK’s Citizen Petition, January 15, 2021, Ex. A at 16).

  • The 2013 Reichmann Citizen Petition In January 2013, an individual named James P.

  • Given the high potential risk to public safety, Valisure seeks to utilize this Citizen Petition to bring these concerns directly to the attention of the Commissioner and FDA, and to request that they take prompt action.

  • Mylan waited until January 2015—six months before Teva was scheduled to enter the market—to file the Citizen Petition even though Teva had been developing the drug for six years, the parties had litigated the patent infringement suit for three years, and the parties settled that litigation three years before the Petition’s filing.

  • The Class Complaint repeatedly alleges that Mylan used the FDA Citizen Petition process as a means to delay Teva’s market entry.

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

  • On a motion to dismiss, the court considers the allegations in the class plaintiffs’ favor and concludes they sufficiently allege that Mylan’s FDA Citizen Petition was objectively baseless.

  • They also support the class plaintiffs’ claim that Mylan’s FDA Citizen Petition delayed Teva’s entry into the market.allegations don’t plead facts capable of supporting a finding or inference that Mylan’s Citizen Petition was objectively baseless.

  • And Mylan’s Citizen Petition never disclosed that it had made such a payment.

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 from time to time in effect affecting the rights of creditors or debtors 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;

  • foreign main proceeding means a foreign proceeding taking place in the State where the debtor has the centre of its main interests;

  • Competition Laws means the Xxxxxxx Antitrust Act, as amended, the Xxxxxxx Antitrust Act, as amended, the HSR Act, the Federal Trade Commission Act, as amended, and all 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 accrue after the commencement of any bankruptcy or insolvency proceeding, whether or not allowed or allowable as a claim in any such bankruptcy or 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 Xxx 0000;

  • 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 bankruptcy, liquidation or other collective judicial or administrative proceedings, including interim proceedings, in which the assets and affairs of the debtor are subject to control or supervision by a court for the purposes of reorganisation or liquidation;

  • 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 loss, relief, allowance, exemption, set-off, deduction, right to repayment or credit or other relief of a similar nature granted by or available in relation to Tax pursuant to any legislation or otherwise;

  • Competition Act Approval means, in respect of the Arrangement, the occurrence of one of the following:

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

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

  • 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 547, 548 and 550 and other “avoidance” provisions of Title 11 of the United States Code, as amended or supplemented).

  • In-Orbit Insurance means, with respect to any Satellite (or, if the entire Satellite is not owned by the Issuer or any Restricted Subsidiary, as the case may be, the portion of the Satellite it owns or for which it has risk of loss), insurance (subject to a right of co-insurance in an amount up to $150.0 million) or other contractual arrangement providing for coverage against the risk of loss of or damage to such Satellite (or portion, as applicable) attaching upon the expiration of the launch insurance therefor (or, if launch insurance is not procured, upon the initial completion of in-orbit testing) and attaching, during the commercial in-orbit service of such Satellite (or portion, as applicable), upon the expiration of the immediately preceding corresponding policy or other contractual arrangement, as the case may be, subject to the terms and conditions set forth in this Indenture.

  • 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.