FDA Letter definition

FDA Letter means the letter attached hereto as Exhibit B duly executed by an authorized officer of Spectrum notifying the FDA of the transfer of the Product Regulatory Files to Par.
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FDA Letter means the letter attached hereto as Exhibit B duly executed by an authorized officer of the applicable Party notifying the FDA of the transfer of the Regulatory Approvals to Shire.
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FDA Letter means the FDA warning letter dated March 26, 2018.
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Examples of FDA Letter in a sentence

  • FDA, Dear ANDA Applicant Letter (Hi-Tech), supra note 293; FDA, Letter to William A.

  • FDA, Dear ANDA Applicant Letter (Hi-Tech), supra note 293, at 16; FDA, Letter to William A.

  • Purchaser and Seller shall file the Purchaser FDA Letter and the Seller FDA Letter, respectively, with the FDA on the Closing Date via overnight courier.

  • The Plan provides various administrative services to two affiliated companies, Access Dental Plan of Utah and Access Dental Service LLC (Delaware).

  • Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers.

  • Operating under 152 “Under a TFM, manufacturers market products at their own risk and are able to make voluntary adjustments taking into account the information presented in the proposed TFM.” See FDA Letter re: FOIA Request, Nov.

  • No. 95, Ex. E attached to Ex. 3 (Affidavit of Gerald Rachanow, Esq.)); FDA Letter to McNeil, Mar.

  • Subject to the approval of the applicable Governmental Authorities, as well as the filing of the Seller FDA Letter and the Buyer FDA Letter with the FDA, all Transferred Permits are freely transferrable to Buyer at the Closing, will be transferred to Buyer at the Closing and will be in full force and effect as of the Closing.

  • Buyer shall send the Buyer FDA Letter to the FDA, and Seller shall send the Seller FDA Letter to the FDA, within ten (10) Business Days of Closing.

  • In the FDA Letter to Healthcare Providers (U.S. FDA, 2021) the FDA highlights that the recent variants targeting gene S should not impact real-time PCR tests targeting other genes.


More Definitions of FDA Letter

FDA Letter means the letter attached hereto as Exhibit B duly executed by an authorized officer of Mylan notifying the FDA of the transfer of the Product ANDA to Cumberland.
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Related to FDA Letter

  • Contract Letter means the letter identifying those documents which form the Contract.

  • Manufacturing and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Post Closing Letter is that certain Post Closing Letter dated as of the Effective Date by and between Collateral Agent and Borrower.

  • Confirmation Letter means a letter issued by any applicable Rating Agency to the effect that neither (a) the resignation of Provident as Servicer under the Servicing Agreement and appointment of Litton as successor Servicer thereunder, nor (b) the amendments exxxxxxated by this Agreement, will adversely affect the then current ratings on the Certificates then being rated.

  • Private Letter Ruling has the meaning set forth in the recitals.

  • Approval Letter means the letter from WRAS to the Applicant confirming the grant of WRAS Approval in respect of a Product;

  • Regulatory Agreement means the regulatory agreement between HPD and the Owner establishing certain controls upon the operation of the Exemption Area during the term of the Exemption.

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Undertaking Letter The letter in substantially the form set forth in Exhibit C of the Trust Agreement.

  • Xxxxxx Agreement means that certain Contingent Stock Agreement, effective as of January 1, 1996, by The Xxxxx Company in favor of and for the benefit of the Holders (named in Schedule I thereto) and the Representatives (therein defined), as amended.

  • Estoppel Letter A document executed by the Cooperative Corporation certifying, with respect to a Cooperative Unit, (i) the appurtenant Proprietary Lease will be in full force and effect as of the date of issuance thereof, (ii) the related stock certificate was registered in the Mortgagor's name and the Cooperative Corporation has not been notified of any lien upon, pledge of, levy of execution on or disposition of such stock certificate, and (iii) the Mortgagor is not in default under the appurtenant Proprietary Lease and all charges due the Cooperative Corporation have been paid.

  • Letter of Intent means the intimation by a letter / email / fax to the bidder that the tender has been accepted in accordance with provision contained in that letter. The responsibility of the contractor commences from the date of issue of this letter and all the terms and conditions of contract are applicable from this date.

  • Commercial Supply Agreement has the meaning set forth in Section 5.2.

  • Welcome Letter means the document entitled “welcome letter” containing important details about this group policy;

  • Commercial Shared-Loss Agreement means the Commercial Shared-Loss Agreement attached to the Purchase and Assumption Agreement as Exhibit 4.15B.

  • UCC Filing Authorization Letter means a letter duly executed by each Loan Party authorizing the Collateral Agent to file appropriate financing statements on Form UCC-1 without the signature of such Loan Party in such office or offices as may be necessary or, in the opinion of the Collateral Agent, desirable to perfect the security interests purported to be created by each Security Agreement and each Mortgage.

  • Closing Press Release has the meaning set forth in Section 5.4(b).

  • Settlement Agreement means this agreement.

  • Environmental and Social Commitment Plan or “ESCP” means the environmental and social commitment plan for the Project, dated May 5, 2023, as the same may be amended from time to time in accordance with the provisions thereof, which sets out the material measures and actions that the Recipient shall carry out or cause to be carried out to address the potential environmental and social risks and impacts of the Project, including the timeframes of the actions and measures, institutional, staffing, training, monitoring and reporting arrangements, and any environmental and social instruments to be prepared thereunder.

  • Instruction Letter means written instructions in a form acceptable to NCPS and executed by Issuer Party with Issuer Party directing NCPS to promptly disburse the Escrow Funds to Issuer pursuant to Section 4(a).

  • License Agreement means the agreement between SAP (or an SAP SE Affiliate, or an authorized reseller) under which Customer procured the rights to use SAP Software or a Cloud Service.

  • Agreement sales and use tax means a tax imposed under: (a) Subsection 59-12-103(2)(a)(i)(A);

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • Control Letter means a letter agreement between Agent and (i) the issuer of uncertificated securities with respect to uncertificated securities in the name of any Credit Party, (ii) a securities intermediary with respect to securities, whether certificated or uncertificated, securities entitlements and other financial assets held in a securities account in the name of any Credit Party, (iii) a futures commission merchant or clearing house, as applicable, with respect to commodity accounts and commodity contracts held by any Credit Party, whereby, among other things, the issuer, securities intermediary or futures commission merchant disclaims any security interest in the applicable financial assets, acknowledges the Lien of Agent, on behalf of itself and Lenders, on such financial assets, and agrees to follow the instructions or entitlement orders of Agent without further consent by the affected Credit Party.

  • Agreement Execution Date means the date this Agreement has been fully executed and delivered by all parties hereto.