Reporting adverse events to the FDA

Sponsor-investigators have reporting responsibilities when adverse events occur in their study. In addition to submitting these events to their IRB, they must also submit in respect to the protocol’s data safety monitoring plan and to the FDA following FDA regulation 21 CFR 312.32(c) or 21 CFR 812.150(a)(1). Reporting of these events to the FDA are required for all IND/IDE holders.

When do you need to submit to the FDA?

What needs to be submitted to the FDA?

The IND/IDE should be submitted to the respective office in the FDA that monitors your IND/IDE: CDER, CBER or CDRH

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