Biologics License Application definition

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 means a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce pursuant to the FDCA.

Biologics License Application means a Biologics License Application, as defined in the U.S. Federal Food, Drug, and Cosmetics Act, as amended, and the regulations promulgated thereunder, and any corresponding foreign or domestic marketing authorization application, registration or certification, necessary or reasonably useful to market a Collaboration Product in the Territory, but not including pricing and reimbursement approvals.

Examples of Biologics License Application in a sentence

• Regulatory The NBA monitors overseas regulatory decisions on products, processes or procedures which are or may be of relevance to its responsibilities.Plasma and recombinant productsThe US Food and Drug Administration (FDA) has approved a Biologics License Application (BLA) from Novo Nordisk for its recombinant coagulation factor VIII, Novoeight.

• Dermatological products marketed without FDA-approval via a New Drug Application, Abbreviated New Drug Application, or Biologics License Application MEDICAL BENEFITS BOOKLETThe Medical Benefits Booklet contains information not found in the prescription drug SPD.

• As per the terms of the collaboration agreement between the two companies, Valneva received a $25 million milestone payment from Pfizer in October following initiation of the Phase 3 study.Pending successful Phase 3 completion, Pfizer could potentially submit a Biologics License Application (BLA) to the U.S. FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2025.Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA154.

• Octapharma Pharmaceuticals submitted a Biologics License Application (BLA), STN BL 125776, for prothrombin complex concentrate (PCC), human-lans.

• Licensed IVD manufacturers must also comply with the commitments and applicable standards in their Biologics License Application (BLA).

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 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.

Biologics License Application means a U.S. License application for a well characterized biologic as provided under applicable U.S. laws and regulations.

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.

Biologics License Application means: (a) a biologics license application submitted to the FDA pursuant to Section 351(a) of the PHSA and the regulations promulgated thereunder, or its successor application; or (b) an application for authorization to market and/or sell a biological product in any country or regulatory jurisdiction other than the United States submitted to the applicable Regulatory Authority in such country or regulatory jurisdiction, including, with respect to the EU, a marketing authorization application submitted either (i) to the EMA pursuant to the centralized EU filing procedure or (ii) to the applicable national Regulatory Authority in an individual EU member state if the centralized EU filing procedure is not used.

Biologics License Application or “BLA” 3