A biologics license application (BLA) is defined by the U.S.
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(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). 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
Some biological products are regulated by the
Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also leg ...
(CDER) while others are regulated by
Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Dir ...
(CBER).
A BLA is submitted after an
investigational new drug has been approved. If the Form 356h is missing information, the FDA will reply within 74 days.
A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number.
After approval, annual reports, reports on adverse events, manufacturing changes, and labeling changes must be submitted.
See also
*
New drug application
*
Investigational new drug
References
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Food and Drug Administration
Intellectual property law
Pharmaceutical industry
American medical research
Drug safety
Experimental drugs
United States federal health legislation
Biotechnology products