BLA

BLA. The FDA required Biologic License Application or a corresponding license required by a Regulatory Authority.

BLA. A Biologics License Application.

BLA. The term "BLA" or "Biologics License Application" shall mean a request to the FDA for permission to introduce, or deliver for introduction, a biologic product into interstate commerce under 21 CFR § 601.2 or its foreign equivalent.

BLA. A Biologics License Application, or similar application for marketing approval of a Licensed Product for use in the Field submitted to the FDA, or a foreign equivalent of the FDA.

BLA. Means a biologicals license application, as defined in the FD&C Act, or any equivalent document filed with the FDA and necessary for the commercial distribution of a biologicals product for humans or any application or other documentation filed with any Regulatory Authority of a country other than the U.S. required for commercial distribution of any biologicals product for humans in that country.

BLA. Means, with respect to a Licensed Product and a jurisdiction, approval or authorization from the relevant governmental authority to market and sell such Licensed Product in the Field in such jurisdiction.

BLA. A Biologic License Application as defined in the United States Food, Drug and Cosmetic Act, filed with the FDA pursuant to Part 600 of Title 21 of the U.S. Code of Federal Regulations, including any amendments thereto.

BLA. Means a Biologic Licensing Application.