Establishment Registration and Drug Listing Compliance Program – DRLS Workshop 2020

FDA discusses a case study of a violation, FDA’s drug listing inactivation project, the compliance case process, manual overrides, top dos and don’ts, and audience questions.

FDA Presenters:
Julian Chun and Leyla Rahjou-Esfandiary
Drug Registration and Listing Staff, CDER


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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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