Upon receipt of the IND application, the FDA assigns an IND number and forward the application to the appropriate reviewing division.
The reviewing division will send a letter or email to the SI providing notification of the IND number assigned, date of receipt of the original application, the address to send future IND submissions, and the name and telephone number of the FDA person to whom questions about the application should be directed.
The FDA is required to respond to an IND sponsor within 30 calendar days of receipt of a complete IND application. An IND goes into effect 30 days after the FDA received the SI may begin the study 30 days after FDA receives the IND application.
After review, the FDA may:
- Grant the IND
- Grant an IND exemption
- The FDA can exempt a clinical investigation of a drug product that is lawfully marketed in the United States from the requirements for an IND if it meets certain criteria [21 CFR 312.2(b)]
- Place the IND Application on a Complete or Partial Clinical Hold
- Holds may require modifications to and resubmission of the protocol to the FDA. If approved, the modifications should be submitted to the IRB
- When a proposed study has been placed on hold, the investigational drug may not be administered to research subjects
In the event the IRB determined that an IND is required, but the FDA disagrees, the investigator must attach documentation of the FDA’s determination that an IND is not needed to the IRB application. This documentation can be an email or letter from the FDA and should be clearly labeled and uploaded in the Sponsor Documentation or Miscellaneous category of the Attachments Page of the IRB application. See Information for Sponsor-Investigators.