Investigational New Drug Application (IND)

IND: Frequently Asked Questions

Pre-IND Stage

IND Application

IND Maintenance

Sponsor-Investigator IND Checklist

Expanded Access IND/Protocol

  • Expanded Access Navigator
    • An online tool to guide patients, caregivers and their physicians through the process for requesting single-patient expanded access for unapproved investigational drugs.
    • Launched by the Reagan-Udall Foundation in collaboration with patient advocacy groups, the pharmaceutical industry, FDA, and others in the Federal government.
    • Provides a directory of companies that provide information on single-patient expanded access.

The final rule does not consider any expanded access use (e.g., access under treatment INDs or treatment protocols, which provide widespread access, access for intermediate-sized patient populations, or access for individual patients) to be an applicable clinical trial.