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
If during the Production of any Batch of a Product, any reprocessing or reproduction is permitted and required in order to meet the Product Specifications, Hanmi will conduct such reprocessing in compliance with cGMP and the BLA.
Any reprocessing, reproduction, or change which is not covered by cGMP or the BLA must be approved in writing by Spectrum prior to implementation.
More Definitions of BLA
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 (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 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 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.
BLA means Biologics License Application.