A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: 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).
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.
This includes: Some biological products are regulated by the Center for Drug Evaluation and Research (CDER) while others are regulated by the Center for Biologics Evaluation and Research (CBER).
If the Form 356h is missing information, the FDA will reply within 74 days.
According to 21 CFR 600.3, FDA interprets "potency" to include effectiveness of the biologic.