Submit Request to Food and Drug Administration (FDA)

• IND or IDE
  • Up to 30-day FDA review period 
  • INDs and IDEs can be submitted to the FDA before submission to the IRB, or they can be submitted to the FDA while the IRB submission is under review. The IRB cannot approve a new IND/IDE study until the FDA determines the investigation may proceed or FDA’s 30-day review period ends. 
• IND exemption
  • Review times can vary; the 30-day FDA review period does not apply to exemption requests. Many are reviewed within 30 days, but there is no published maximum review period. 
• Pre-IND
  • The FDA will respond to the request for a meeting or a written response within 21 days of receipt.
  • If requesting a meeting, the FDA will schedule the Pre-IND meeting 60 days from receipt. If requesting a written response, the FDA will provide a written response 60 days from receipt.
  • A Pre-IND meeting package must be sent to the FDA no later than 30 days before the scheduled meeting date or written response.
• Q-Submission
  • The Q-Submission Program (Q-Sub) provides mechanisms for investigators and sponsors to request feedback from, or a meeting with, the FDA regarding medical devices. 
  • The timelines for feedback from the FDA depend on the type of Q-Sub request, ranging from 70-90 days.

The type of product under investigation (drug, biologic, or device) and the appropriate Center at the FDA will determine the submission method. Indiana University does not have an institutional account to submit in Electronic Common Technical Document (eCTD) format to the FDA via Electronic Submissions Gateway (ESG). Instead, there are alternative processes for investigator-sponsored INDs and IDEs:

• • For drugs regulated by the Center for Drug Evaluation and Research (CDER): 
    • • submit online via CDER NextGen Portal
  • For biologics and devices regulated by the Center for Biologics Evaluation and Research (CBER): 
    • • submit a hard copy of the cover letter plus an eCopy via FedEx to the CBER Document Control Center.
  • For devices regulated by the Center for Devices and Radiological Health (CDRH): 
    • • Submit a hard copy of the cover letter plus an eCopy via FedEx to the CBER Document Control Center.

IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information
For Cancer Center Trials (studies involving cancer patients):

• • The Protocol Development team in the IUSCCC Clinical Trials Office can advise on the FDA submission process for Cancer Center trials. For more information, visit the IU Cancer Center.
  • For cellular therapy trials, refer to Cellular Therapy & Immune Effector Cell Trials. 

FDA

• • Center for Drug Evaluation and Research (CDER)
    • • CDER Next Gen Portal FAQs 
      • Submitting Research INDs and subsequent amendments via CDER NextGen Portal 
  • Center for Biologics Evaluation and Research (CBER)
    • • Submission of Regulatory Applications (SOPP8110) 
  • Center for Devices and Radiological Health (CDRH)
    • • Guidance: eCopy Program for Medical Device Submissions 
      • eCopy Medical Device Submissions 

NIH Regulatory Toolbox:

• • Drugs and Biologics:
    • Initial IND Application 
    • How Can I Receive an IND Exemption? 
    • FDA Responses and Meetings for Investigational New Drug Applications and Pre-INDs 
  • Devices:
    • Initial IDE Submission
    • Q-Submissions for Devices