Arabic Arabic English English French French German German
dark

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-human-drugs/investigator-responsibilities-safety-reporting-investigational-drugs-and-device
——————– 
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/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2021 Playlist – https://youtube.com/playlist?list=PLey4Qe-UxcxYS1MaTusSgyifQDqdeepyD
SBIA LinkedIn – https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources – https://www.fda.gov/cdersbialearn
Twitter – https://twitter.com/FDA_Drug_Info
Email – CDERSBIA@fda.hhs.gov
Phone – (301) 796-6707 I (866) 405-5367

Read More

Total
0
Shares
Leave a Reply

Your email address will not be published. Required fields are marked *

Previous Post

Advancing Generic Drug Development: Translating Science to Approval, Day Two Closing Remarks

Next Post

Study: Levels of glyphosate represent low health risk to breastfeeding mothers in Spain

Related Posts
Total
0
Share