The FDA has 30 days from receipt of the IND to contact the sponsor with issues that need to be resolved before the clinical trial can begin. If the FDA does not contact the sponsor by day 30, it is assumed that there are no problems and the sponsor can proceed with the protocol.
Once the sponsor is notified of issues, the sponsor has 30 days to either:
- Amend the protocol, get FDA approval of the amendment, then proceed with the protocol
- Not amend, and/or the amendment is not approved by the FDA; protocol is placed on clinical hold until all of the issues are addressed