FDA Investigational New Drug (IND)

Resources for IND Applications:

The following resources include:

• General information from the FDA regarding INDs
• FDA Forms
• Where to send the application
• CFRs
  • 21CFR312
  • 21CFR213.23 (IND application content and format)

Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, the FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.