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Biologic License Application (BLA)
Biologic License Application (BLA)
Biological products are approved by the FDA, for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A BLA is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical effects of the biologic product. If the information provided meets FDA requirements, the application is approved, and a license is issued allowing the firm to market the product.