21 CFR 312.32 - IND Safety Reporting

What it says

Sponsors of investigational new drug studies must promptly review all information relevant to the safety of the drug and notify FDA and all participating investigators in an IND safety report of potential serious risks from clinical trials or any other source. Reports are required for serious and unexpected suspected adverse reactions, findings from other studies or animal tests that suggest a significant risk, and increased rates of occurrence of serious suspected adverse reactions. Most reports are due within 15 calendar days, and unexpected fatal or life-threatening suspected adverse reactions within 7 calendar days.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The sponsor, not the investigator, makes the call on whether an event is a suspected adverse reaction that must be reported.
• Timelines run from the time the sponsor determines that the information qualifies for reporting.
• Aggregate analysis matters, since a pattern across events can trigger reporting even when individual cases do not.

What FDA inspectors look for

• Whether safety information from all sources is reviewed and assessed.
• Whether reports were submitted within the required timelines.
• Whether investigators were notified of safety findings as required.

Related regulations