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  1. Clinical Trials and Human Subject Protection

IND/IDE Contacts

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
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 biologics (other than gcp questions)