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, or similar application, submitted to the applicable Competent Authority in a jurisdiction in the Territory.
Examples of BLA in a sentence
Work shall include but not be limited to drafting, updating, and reviewing the following sections: • General Provisions • Right to farm • Definitions • Use table consistency • Update common processes to include all specific processes covered by development code: o Master Plan Amendment o Update all mapping processes including tentative and final parcel maps and subdivision maps, reversion, abandonment, BLA, etc.
More Definitions of BLA
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.
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 basic liquidity adjustment which is 0% or 25% as determined by Fitch in accordance with the Fitch Criteria;
BLA means a Biologics License Application to the FDA or an equivalent application to any other Government Authority within the Territory requesting market approval for a new biological product (or a New Drug Application (NDA), or equivalent application, in the event that the FDA or other Government Authority determines that an NDA, rather than a BLA, is the appropriate mechanism for requesting such approval).
BLA means a human biologics license application submitted under Section 351(a) of the Public Health Service Act.
BLA means, as applicable, a Biologics License Application (as defined in 21 C.F.R. 600 et seq.), or a New Drug Application (as defined in 21 C.F.R. Parts 314 et seq.) or, in each case, its successor regulation.
BLA means (i) (x) a biologics license application (as defined in the FD&C Act) to introduce, or deliver for introduction, a biologic product, including vaccines into commerce in the U.S., or any successor application or procedure and (y) any similar application or functional equivalent relating to biologics licensing applicable to or required by any non-U.S. Governmental Authority, and (ii) all supplements and amendments that may be filed with respect to the foregoing.