How to Update Orange Book Information

FDA discusses updates to Orange Book information including transfer of ownership of an application, application holder name changes, reports required by section 506I of the Federal Food, Drug, and Cosmetic Act, and user fee implications.

Presenters include CAPT Kendra Stewart and CDR Kun Shen from CDER Office of Generic Drugs and CAPT Eunice Chung-Davies from CDER Office of Management.

FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.  
 
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