503B Product Reporting for Compounding Outsourcing Facilities (7/7) Drug Registration & Listing 2018

Drug Registration and Listing Staff Lysette Deshields and Soo Jin Park provide a walk-through of the creation of a 503B product report submission using CDER Direct.
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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