Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices | FDA –

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Not for implementation. Contains non-binding recommendations.
This guidance is intended to help clinical investigators comply with the following safety reporting requirements:
Recommendations are provided to help investigators identify the following:
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document’s docket number: FDA-2021-D-0368.
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