Trial City
Back to Ask the city
Safety

Where are the IND safety reporting rules, with the timelines?

City HallOct 14, 2026

1 answer

FDA's guidance Safety Reporting Requirements for INDs and BA/BE Studies explains the requirements for reporting safety information during IND studies.

Official sourcewww.fda.gov
City HallOct 14, 2026
0 found this helpful

Answer this question