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 Biological License Application (as defined by the FDA) or its foreign equivalent (or any successor application having substantially the same function).

Examples of BLA in a sentence

• And AstraZeneca would have the certainty that the statutory definition of Qualifying Single Source Drug applies—freeing it to develop and commercialize products sharing FARXIGA’s single-ingredient active moiety that are approved under a new NDA or BLA.

• The Government suggests that whether a new application is submitted under a different NDA or BLA is “in many instances, a feature of how the applicant chooses to submit its application(s) to [FDA].” D.I. 21-1 at 15.

• Photo- stimulation is depicted by the black bar.D) Example of traces of postsynaptic membrane potential recorded from individual FrA L2/3 pyramidal neurons upon WGN paired (top) or not (bottom) with the photo- stimulation of ChR2-expressing BLA neurons.

• Black and blue bars below the traces indicate the duration of the stimulation.E) Averaged cVm change (± sem) observed upon paired stimulation (solid line) or expected from the arithmetic sum of individual depolarizations evoked by the stimulation of BLA or auditory tones alone (dotted line).

• Thus, a new drug product or therapy with the same single-ingredient active moiety as FARXIGA—even if it is approved under a different NDA or BLA under FDA’s rules3—will immediately be subject to the Maximum Fair Price for FARXIGA, without regard to the statutory seven-year minimum that would otherwise apply before a drug is selected for price negotiation.D.I. 19 (AstraZeneca’s Opening Br.), Ex. 1 (Initial Guidance) at 8; Ex. 2 (Final Guidance) 99.

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, 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 (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 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 Biologics License Application.

BLA means a Biologics License Application as described in Title 21 of the U.S. Code of Federal Regulations, Part 601, et seq., that is submitted to the FDA in order to gain the FDA’s approval to commercialize a biologic product in the United States for the indications set forth in such BLA.

BLA means basic liquidity adjustment which is 0% or 25% as determined by Fitch in accordance with the Fitch Criteria;