Investigator Responsibilities - Safety Reporting for Investigational Drugs and Devices скачать в хорошем качестве

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.” For slides and additional information: https://www.fda.gov/drugs/news-events... --------------------  FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.   Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367