Prior Approval Supplement definition

Prior Approval Supplement means a change in the manufacture or testing of the Product that may be applicable to either a specific batch of Product or all Product that requires FDA approval prior to implementation of such change or sale of the Product.
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Prior Approval Supplement has the meaning given to it in section 506A of the Federal Food, Drug, and Cosmetic Act and §314.70(b) in the Code of Federal Regulations.
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Examples of Prior Approval Supplement in a sentence

  • If FDA does not advise the manufacturer within 30 days of submission of the supplement that the change requires approval prior to distribution of the product (i.e., a Prior Approval Supplement), the manufacturer may distribute product manufactured using the change pending approval of the supplement.

Related to Prior Approval Supplement

  • Prior Approval means written ap- proval by an authorized official evi- dencing prior consent.

  • Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.

  • Requisite Approval means the affirmative vote of the holders of (a) at least a majority of the outstanding shares of Company Capital Stock, voting together as a single class and (b) at least a majority of the outstanding shares of Series A-1 Preferred Stock, Series B Preferred Stock and Series C Preferred Stock, voting together as a single class on an as-converted basis.

  • Major Amendment means any change which is not a minor amendment.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • Final Approval Date means the date on which the Court enters its Order and Judgment approving the Settlement.

  • Stockholder Approval Date means the date on which Stockholder Approval is received and deemed effective under Delaware law.

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • Stockholder Approval means such approval as may be required by the applicable rules and regulations of the Nasdaq Stock Market (or any successor entity) from the stockholders of the Company with respect to issuance of all of the Warrants and the Warrant Shares upon the exercise thereof.

  • Initial Budget has the meaning set forth in Section 7.06(a).