Investigator Responsibilities - Safety Reporting for Investigational Drugs and Devices

CDER’s Paul Gouge, JD, provides background on investigator safety reporting and describes the new guidance entitled, “Investigator Responsibilities - Safety Reporting for Investigational Drugs and Devices.”

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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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