BLA Booklet

The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. The BLA related regulations govern cellular products, gene therapy products, vaccines/vaccine-associated products, and some other biologic products.

The BLA booklet App presents the regulations for biologics licensing in a user-friendly e-format. The users can easily reach to each section of regulations with customized view options. This is a convenient information and reference tool for all people working in pharmaceutical and biotech industry.

Keywords : Biologics Licensing, BLA, new biological product, drug approval, FDA, Regulation, Regulatory