IND in effect

When can you start dosing under an IND?

Role: Regulatory Affairs / Clinical Operations

Context: Your company has submitted an IND to the FDA. Today is day 25 after the FDA received the IND. You have not received any hold letter or request for information.

Task: Decide whether the sponsor can initiate the Phase 1 study and dose the first subject tomorrow (day 26).

Step 1 of 1

IND effectiveness

info

Under 21 CFR 312.40, an IND goes into effect 30 days after the FDA receives it, unless the FDA notifies the sponsor that the IND is on clinical hold. No hold has been issued.

Can the sponsor dose the first subject on day 26?