new FDA guidance – Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices

Written by Steen Ottosen

on 28 October 2021

The FDA has published a new draft guidance to help Investigators comply with the safety reporting requirements in Clinical Trials 21-September-2021.

Recently, the recommendations for investigators provided in the 2012 final guidance were updated, merged, and published for notice and comment purposes in the draft guidance for industry Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies (June 2021) (the merged 2021 draft guidance). That merged 2021 draft guidance does not, however, include the recommendations for investigator responsibilities that are included in the 2012 final guidance. Those specific recommendations on investigator responsibilities are the primary focus of this new guidance. Which can also be downloaded here

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