IND/IDE Contacts

Questions about biologics (other than gcp questions)

• 800-835-4709 or 240-402-8010
  [After the greeting, consumers and healthcare professionals press 1, manufacturers press 2, or for Freedom of Information Act requests press 3.]
• OCOD@fda.hhs.gov (consumers)
• Industry.Biologics@fda.gov (manufacturers' assistance)
• Questions about whether a product is subject to IND regulations: call 800-835-4709 or 240-402-8010

Questions about drug products (other than gcp questions)

• 301-796-3400
• Druginfo@fda.hhs.gov
• Questions about whether a product is subject to IND regulations: call 301-796-3400

Questions about medical devices (other than gcp questions)

• DICE Web Page
• Manufacturer's assistance: 800-638-2041
• Consumer assistance: 888-INFO-FDA
• Questions about whether a product is subject to IDE regulations: call 301-796-5640