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 (as defined in 21 C.F.R. 600 et. seq.), MAA or substantially similar application or submission filed with a Regulatory Authority in a country or group of countries to obtain Regulatory Approval to market a product in that country or in that group of countries, and any amendments thereto.
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 a biologics license application that is submitted to the FDA for a Licensed Product, pursuant to 21 C.F.R. § 601.2.
BLA means Biologics License Application.
BLA means a Biologics License Application filed pursuant to the requirements of the FDA, or the international equivalent of such application in another country.
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.