Definition of Biologic License Application (BLA)

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TeachMeFinance.com - explain Biologic License Application (BLA)



Biologic License Application (BLA)

The term 'Biologic License Application (BLA)' as it applies to the area of the U.S. Food and Drug Administration can be defined as ' Biological products are approved 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 biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects 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'.

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About the author

Mark McCracken

Author: Mark McCracken is a corporate trainer and author living in Higashi Osaka, Japan. He is the author of thousands of online articles as well as the Business English textbook, "25 Business Skills in English".


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