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

• 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 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.

• It is expected that the prototypes will be stored by Offeror until such time as (a) they can be used for pre-clinical or clinical development purposes under an Investigational New Drug application (IND), or (b) upon the FDA’s grant of an EUA under Section 564 of the Food, Drug and Cosmetic Act (FD&C Act), or full marketing approval under a full Biologics License Application (BLA) under Section 351(a) of the Public Health Service Act (PHSA).

• CytoDyn plans to seek FDA approval for leronlimab (PRO 140) in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication.

• The Awardee will serve as the Sponsor of the Regulatory Application (an Investigational New Drug Application (IND), Investigational Device Exemption (IDE), New Drug Application (NDA), Biologics License Application (BLA), Premarket Approval Application (PMA), or 510(k) Pre-Market Notification Filing (510(k)) or another regulatory filing submitted to FDA) that controls research under this agreement.

More Definitions of Biologics License Application

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 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 filing under 21 C.F.R. §§ 600-680 filed pursuant to the United States Food & Drug Act or any application or submission for Regulatory Approval of a biologic product filed with a Regulatory Authority that is the equivalent thereof.

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 or “BLA” means with respect to (i) the United States, an application requesting permission from the FDA to introduce, or deliver for introduction, a Product (as a biological product) into interstate commerce (as more fully defined in 21 CFR 600, et. seq.) or (ii) outside the United States, any similar application or submission for marketing authorization of a Product filed with the applicable Regulatory Authority in the applicable jurisdiction.

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.