BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.
BLA means a Biologics License Application, for which Regulatory Approval by the FDA is required to market a Product in the U.S.
BLA means a biologics license application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time) filed with the FDA seeking Regulatory Approval to market and sell any Licensed Product in the United States for a particular indication within the Field.
Examples of BLA in a sentence
Bxxxx agrees to submit information to the FDA consistent with the information set forth in 21 CFR § 314.72 committing to agreements, promises and conditions made by Seller and contained in the Product BLA and specifying the date the change of ownership is effective, substantially in the form of the document as provided in Schedule IX.
More Definitions of BLA
BLA means a Biological License Application (as defined by the FDA) or its foreign equivalent (or any successor application having substantially the same function).
BLA means (a) a Biologics License Application as defined in the FD&C Act and the regulations promulgated thereunder, (b) a Marketing Authorization Application (“MAA”) in the European Union, or (b) any equivalent or comparable application, registration or certification in any other country or region.
BLA means a Biologics License Application.
BLA means basic liquidity adjustment which is 0% or 25% as determined by Fitch in accordance with the Fitch Criteria;
BLA means a Biological License Application for a Product that is submitted to the FDA pursuant to 21 C.F.R. § 601.2.
BLA means a biologics license application or equivalent application that is filed with the FDA to obtain Regulatory Approval for a Licensed Product in the United States or any comparable application filed with a Regulatory Authority of a country or group of countries in the Territory other than the United States to obtain Regulatory Approval for Licensed Product in that country or in that group of countries.
BLA means a Biologicals License Application (as more fully defined in 21 C.F.R. 601 et. seq., or its successor provisions) and all amendments and supplements thereto.