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Biologics License Application [BLA]

A Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. The BLA is a submission to the FDA that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. A BLA is submitted after an investigational new drug has been approved. 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.

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