FDA Approval Letter definition

FDA Approval Letter means the letter, dated June 15, 2021, from the FDA to Seller, approving the BLA for allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat labeled with the proprietary name STRATAGRAFT (submission tracking number BL 125730).
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FDA Approval Letter means the letter, dated April 27, 2017, from the Department of Health and Human Services to Seller, Reference ID 4090146, regarding the approval of the BLA (761052) for Brineura (cerliponase alfa).
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FDA Approval Letter means the letter, dated November 9, 2023 issued by the FDA to Seller evidencing the approval of BLA 125777 for Chikungunya Vaccine, Live, and granting the Priority Review Voucher.
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Examples of FDA Approval Letter in a sentence

  • The Contractor shall provide a single Point of Contact (POC) to maintain and execute contract, and a single Support Analyst who shall provide day-to-day support to the Contractor PM.

  • Id. ¶¶ 9-10; Exhibit “A” to Am. Compl., May 9, 2006, FDA Approval Letter, ECF No. [6-1] (“PMA Approval Letter”) at 1, 6-9.After being diagnosed as requiring a hip replacement, Mink’s orthopedic surgeon scheduled the surgery with a competing manufacturer’s system.

  • Seller has provided to Buyer true and complete copies of the FDA Approval Letter, the Plan and the GUC Trust Agreement and any other material communications between Seller or any of its Affiliates and the FDA and the GUC Trustee, in each case regarding the Priority Review Voucher or the sale thereof.

  • Seller has provided to Buyer a true, correct and complete copy of the FDA Approval Letter acknowledging the Priority Review Voucher.

  • The FDA safety requirements for chemical abortion in 2000 included:● Pregnancies must be less than 50 days gestation (7 weeks)● Three in-person office visits required● Supervision by a qualified physician● All adverse events must be reportedSee FDA Approval Mem., Mifeprex; FDA Approval Letter, Mifeprex (Sept.

  • For example, Article 1 establishes the High Level Commission for the Prevention and Control of COVID-19.

  • Relevant documents include: FDA Approval Letter FDA-EIR Findings EC Certificate 1.9Any statement of work or other documentation of contracting work.

  • Seller and BPI have provided to Buyer true and complete copies of the FDA Approval Letter, the rare pediatric disease designation issued by the FDA for Brineura (cerliponase alfa) and all other correspondence received by Seller, BPI or any of their respective Affiliates from the FDA regarding the Priority Review Voucher.

  • See August 18, 2014, FDA Approval Letter for Mylan’s ANDA No. 202881 (“We have completed the review of this ANDA and have concluded that adequate information has been presented to demonstrate that the drug is safe and effective for use as recommended in the submitted labeling.”).Second, the commercial events of the last two days have proved that a recall is a remedy drastically broader than necessary to prevent Hospira from suffering irreparable harm.

  • There is no term or condition imposed by the FDA on the Priority Review Voucher that is not set forth in the FDA Approval Letter as of the date hereof.


More Definitions of FDA Approval Letter

FDA Approval Letter means the letter, dated November 19, 2021, from the FDA to Seller, Reference ID 4905458, regarding the approval of the NDA 214938 for Voxzogo (vosoritide).
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Related to FDA Approval Letter

  • FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.

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

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • 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.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • 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.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Price Approval means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • ANDA means Abbreviated New Drug Application.

  • Preliminary Approval Order means the order preliminarily approving the Settlement Agreement, certifying the Settlement Class for settlement purposes, and directing notice thereof to the Settlement Class, which will be agreed upon by the Parties and submitted to the Court in conjunction with Plaintiffs’ motion for preliminary approval of the Agreement.

  • 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.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • PMA means the annual product multiplier and/or seasonal factor as appropriate for Gas Year “t”, in accordance with the Gas Product Multipliers and Time Factors Table.