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 FDA warning letter dated March 26, 2018.
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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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Examples of FDA Letter in a sentence

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

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

  • Geier, 529 U.S. at 886.The District Court concluded that “the FDA’s Advisory and Backgrounder are entitled to deference and [] the FDA Letter is persuasive.” Fellner v.

  • FDA Letter from Mitchell Cheeseman to Neal Earhart of Ciba Specialty Chemicals Corporation, Nov.

  • Thus, the FDA’s participation in the regulatory process was limited to reviewing the purveyor’s conclusion that FDA approval was not required, in light of whatever information the purveyor voluntarily supplied, and issuing a letter indicating that it had “no further questions.” See FDA Letter to Okanagan Specialty Fruit Inc., (Mar.

  • FDA, Letter of Authorization to BARDA, March 28, 2020, https://www.fda.gov/media/136534/download.

  • We have also built research partnerships with a wide range of successfulcompanies in the food sector.

  • Because “Vanilla extract (21 CFR 169.175) and vanilla flavoring (21 CFR 169.177)do not provide for the use of vanillin,” it is deceptive to give consumers the impression a product containing added vanillin contains “natural vanilla flavors.” Exhibit “J,” FDA Letter, Cataline Ferré-Hockensmith to Richard Brownell, April 19, 2005, pp.

  • 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.

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


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

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

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  • Private Letter Ruling shall have the meaning set forth in the Recitals.

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  • 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 6.1.

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  • 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.

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

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  • 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.

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  • Supply Agreement has the meaning set forth in Section 7.2.