Biologics License Application definition

Biologics License Application or “BLA” means a Biologics License Application (as more fully described in U.S. 21 C.F.R. Part 601.20 or its successor regulation) and all amendments and supplements thereto submitted to the FDA, or any equivalent filing, including an MAA, in a country or regulatory jurisdiction other than the U.S. with the applicable Regulatory Authority, or any similar application or submission for Regulatory Approval filed with a Regulatory Authority to obtain marketing approval for a biologic product in a country or in a group of countries.
Biologics License Application or “BLA” means a Biologics License Application and amendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. Section 600 et seq., for FDA approval of a Product and “sBLA” means a supplemental BLA, and any equivalent or a New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder, and any corresponding non-U.S. marketing authorization application, registration or certification, necessary to market a Product in any country outside the U.S., but not including applications for pricing and reimbursement approvals. *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.

Examples of Biologics License Application in a sentence

  • Wound care products, including oral rinses, marketed without FDA-approval via a New Drug Application, Abbreviated New Drug Application, or Biologics License Application.

  • Dermatological products marketed without FDA-approval via a New Drug Application, Abbreviated New Drug Application, or Biologics License Application.

  • The Vendor acknowledges that each Product has, if required by law, an FDA- certified New Drug Application, an Abbreviated New Drug Application, or a Biologics License Application on file and accepts the liability with which such application confers.

  • The anticipated regulatory strategy (e.g., additional nonclinical or clinical studies anticipated/required, FDA or regulatory authority meetings desired, industry partnerships) for movement of the research into later phases of development and to support a potential marketing application [e.g., New Drug Application, Biologics License Application, Premarket Approval Application, 510(k)].

  • Womack commanded launch crews inside of silos in both Arkansas and California during the first ten years of the Titan II program.


More Definitions of Biologics License Application

Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.
Biologics License Application means an application for licensure of a biological product submitted to the FDA under 42 U.S.C. § 262(k) for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.
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.
Biologics License Application and “BLA” mean an application for permission to market a biologic product submitted to a Regulatory Authority to obtain Regulatory Approval for marketing a Licensed Product in a country or region.
Biologics License Application or “BLA” means a Biologics License Application submitted to the FDA under subsection (a) or (k) of Section 351 of the FFDCA or any corresponding foreign application in the Territory, including, with respect to the European Union, a marketing authorization application filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in Europe (including Great Britain) with respect to the mutual recognition or any other national approval.
Biologics License Application or “BLA” means a Biologics License Application in the United States as described in Section 351(a) of the United States Public Health Service Act (PHS Act), an abbreviated Biological License Application as described in Section 351(k) of the PHS Act, or equivalent application filed with the applicable Regulatory Authority in another country or regulatory jurisdiction in the Territory.