FDA Notice definition

FDA Notice has the meaning set forth in Section 5.01(hh).
Sample 1Sample 2
FDA Notice has the meaning provided in Section 7.13.
Sample 1Sample 2
FDA Notice has the meaning set forth in Section 7.01(ff).
Sample 1

Examples of FDA Notice in a sentence

  • FCHPs and PCOs shall not authorize payment for any Drug Efficacy Study Implementation (DESI) Less Than Effective (LTE) drugs which have reached the FDA Notice of Opportunity for Hearing NOOH) stage, as specified in OAR 410-121-0420 (DESI)(LTE) Drug List.

  • See FDA Notice, Guidance for Industry, “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs,” August 6, 2015.D. Why Defendants’ Marketing Messages Are Misleading and Unfair.

  • Whereas Company is requested to perform analyses on imported goods placed on Detention by the Food and Drug Administration (FDA), you will grant Company and its employees or agents, full access to the entire shipment as detailed on the FDA Notice of Action.

  • The FDA initially regulated ozone in medical devices because “[i]n order for it to be effective as a germicide, ozone must be present in a concentration far greater than that which can be safely tolerated by man and animals.” FDA Notice of Proposed Rulemaking, 37 Fed.

  • MCEs may not authorize payment for any Drug Efficacy Study Implementation (DESI) Less Than Effective (LTE) drugs that have reached the FDA Notice of Opportunity for Hearing (NOOH) stage, as specified in OAR 410-121-0420 (DESI)(LTE) Drug List.

  • The FDA found that “in tests conducted to study the bactericidal properties of ozone, test animals have died before the bacteria were completely destroyed.” FDA Notice of Proposed Rulemaking, 37 Fed.

  • This Agreement shall automatically terminate at the end of such [***] period unless the Parties mutually agree that issues raised in the FDA Notice have been resolved.

  • FDA, Notice of Availability, Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning a Genetically Engineered Atlantic Salmon, 77 Fed.

  • See FDA, Notice of Public Hearing, Labeling of Food Made from AquAdvantage Salmon, 75 Fed.

  • See FDA Notice, Guidance for Industry, “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs,” August 6, 2015.

Related to FDA Notice

  • CAFA Notice refers to the notice requirements imposed by 28 U.S.C. § 1715(b).

  • Opt-Out Notice has the meaning specified therefor in Section 2.02(a) of this Agreement.

  • Publication Notice means the summary notice of proposed Settlement and hearing for publication substantially in the form attached as Exhibit 3 to Exhibit A.

  • Pre-Notice shall have the meaning ascribed to such term in Section 4.13.

  • Selection Notice means a notice substantially in the form set out in Part II of Schedule 3 (Requests) given in accordance with Clause 9 (Interest Periods).

  • Denial notice means a board notification denying an application for the issuance or renewal of a license as required by the Act.

  • Nomination Notice means all information and documents that a Nominating Stockholder is required to submit to the Secretary of the Corporation pursuant to Section 1.13(f).

  • Initial Notice shall have the meaning set forth in Section 7.1.

  • Election Notice has the meaning set forth in Section 11.01(b).

  • Rectification Notice means a notice in writing that identifies a defect in a work and requires rectification of the defect within a specified period of time.

  • Approval Notice means, with respect to any Eligible Loan Asset, the written notice, in substantially the form attached hereto as Exhibit A, evidencing the approval by the Administrative Agent, in its sole discretion, of the conveyance of such Eligible Loan Asset by the Transferor to the Borrower pursuant to the terms of the Purchase and Sale Agreement and the Loan Assignment by which the Transferor effects such conveyance.

  • CFIUS Notice means a joint voluntary notice with respect to the Transactions prepared by the parties hereto and submitted to CFIUS in accordance with the requirements of the CFIUS Statute.

  • Rejection Notice has the meaning specified in Section 2.05(b)(v).

  • Delivery Notice Has the meaning specified in the NPA.

  • Dispatch Notice means a notice delivered by CAISO to Owner’s Scheduling Coordinator on a daily, hourly or real-time basis requesting dispatch of one or more Unit(s) to provide Energy or Ancillary Services under this Agreement. Dispatch Notices include: (a) Day-Ahead Schedules and Real-Time Dispatches where the RMR Unit or Units are flagged as RMR Dispatches as a result of the Market-Power Mitigation and Reliability Requirements Determination processes pursuant to the CAISO Tariff, (b) Manual RMR Dispatch Notices, (c) notices deemed to have been given by CAISO for the Energy actually Delivered by a Unit that starts or increases Energy output as a result of a “system emergency” as defined in the CAISO Tariff whether the start or increase occurs automatically (for Units specified in Section 2 of Schedule A as having the ability to Start-up or ramp automatically) or pursuant to a standing written order of the CAISO, and (d) Test Dispatch Notices given by CAISO under Section 4.9 other than Test Dispatch Notices issued at Owner’s request to test Availability or heat input of the Unit.

  • Final Notice shall have the meaning assigned thereto in Section 5(g)(iii) hereof.

  • Offering Notice has the meaning set forth in Section 3.1(a).

  • Notice of Revocation means, in connection with the revocation by a Beneficial Owner or its Agent Member of its Notice of Tender, a notice, substantially in the form attached to the Tender and Paying Agent Agreement, delivered by a Beneficial Owner or its Agent Member to the Tender and Paying Agent indicating an intention to revoke the tender of some or all of the VRDP Shares for sale on a Purchase Date pursuant to Section 1 of Part II of this Statement.

  • Reminder Notice means a notice in writing issued in accordance with clause 7.1(1)(a).

  • Mediation Notice is defined in Section 6.2(b).

  • Required Notice Period means the number of days required notice set forth below applicable to the Aggregate Reduction indicated below: Aggregate Reduction Required Notice Period £$100,000,000 two Business Days >$100,000,000 to $250,000,000 five Business Days ³$250,000,000 ten Business Days

  • Long Form Notice means the long form notice to be made available on the Settlement Website, describing the terms of this Settlement Agreement and containing information on how to file a claim or object, substantially in the form of Exhibit B hereto.

  • Sales Notice shall have the meaning ascribed to such term in Section 2(b)(i).

  • Auction Notice has the meaning assigned to such term in the definition of “Dutch Auction”.