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 under 21 CFR 600 – 680. 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. Form 356h specifies the requirements for a BLA. This includes: - Applicant information - Product/Manufacturing information - Pre-clinical studies - Clinical studies - Labeling Source: [FDA | Biologics License Applications (BLA) Process (CBER)](https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber)