BLA definition
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 complete biologics license application as defined in, and containing the content, and in the format, required by 21 C.F.R. § 600 et seq filed with the FDA, or a corresponding application with a Regulatory Authority in a country other than the United States, together with all replacements, additions, deletions, and supplements thereto.
Examples of BLA in a sentence
For clarity, the delay in acceptance for review or approval of a BLA, which is caused by the FDA, shall not constitute Purchaser’s failure to use Commercially Reasonable Efforts.
More Definitions of BLA
BLA means a Biologics License Application filed with the FDA and/or any other application required for the purpose of marketing or selling or using a therapeutic or prophylactic product to be filed with a governmental agency in a non-U.S. country or group of countries, including, without limitation, a Product License Application or Marketing Authorization in the European Union.
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.
BLA means basic liquidity adjustment which is 0% or 25% as determined by Fitch in accordance with the Fitch Criteria;
BLA means Biologics License Application.
BLA means (a) a biologics license application as that term is used in defined in the PHS Act and the regulations promulgated thereunder, (b) a marketing authorization application in the European Union, or (c) any equivalent or comparable application, registration or certification in any other country or region.
BLA means a Biologics License Application submitted to the FDA pursuant to Section 351 of the Public Health Service Act (42 U.S.C. § 262) and the FDA’s implementing regulations at 21 C.F.R. Part 601.
BLA means a Biologic License Application (as more fully described in U.S. 21 C.F.R. Part 601.20 or its successor regulation), as may be amended from time to time, or any analogous application or submission with any Regulatory Authority outside of the United States.