To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing addresses in § 600.2(a) or (b) of this chapter), on forms ...

The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated...

A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of...

The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.

Aug 4, 2023 · The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). Key resources and...

A Biologics License Application (BLA) is for biological products such as vaccines, blood products, and gene therapies, while a New Drug Application (NDA) is for the approval of small-molecule drugs and certain other therapeutic agents.

What standard does FDA use to approve a Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act (PHSA)? What goes in a BLA? What is FDA’s process for reviewing a BLA? DiMasi et al., J. of Health Economics (2016);47:20-33.

Sep 10, 2024 · A Biologics License Application (BLA) is a comprehensive submission to the FDA requesting approval to distribute a biologic product across state lines. Biologics, derived from living organisms, encompass a range of products, including vaccines, blood components, allergenic products, and cellular and genetic therapies.

Dec 24, 2024 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 601.2 - Applications for biologics licenses; procedures for filing. § 601.3 -...

One biologics license shall be issued to cover all locations meeting the establishment standards identified in the approved biologics license application and each location shall be subject to inspection by FDA officials.