BLA definition

BLA means a Biologics License Application filed with the FDA in the United States with respect to a Licensed Product, as defined in Title 21 of the U.S. Code of Federal Regulations, Section 601.2 et seq.

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 a Regulatory Authority.

Examples of BLA in a sentence

• In addition, under 21 CFR 601.70 you should include a status summary of each commitment in your annual progress report of postmarketing studies to this BLA.

• Remote BLA/SCA Limitation for Hosted VoIP: The Remote BLA or Remote SCA VoIP functionality for the VoIP Service allows Customer to program its equipment to ring in two separate locations when a single phone number is dialed (i.e., the end user’s house and business).

• Facility information and data provided in the BLA were reviewed by CBER and found to be sufficient and acceptable.

• Submit nonclinical and chemistry, manufacturing, and controls protocols and all postmarketing final reports to this BLA.

• Also within 14 days, amend all pending supplemental applications that include labeling changes for this BLA, including pending “Changes Being Effected” (CBE) supplements, for which FDA has not yet issued an action letter, with the content of labeling [21 CFR 601.12(f)] in Microsoft Word format that includes the changes approved in this supplemental application, as well as annual reportable changes.

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 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 Biologics License Application, or similar application that is submitted to the applicable Regulatory Authority for marketing approval of a Product in a given jurisdiction. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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 human biologics license application submitted under Section 351(a) of the Public Health Service Act.

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.