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Science & Research

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IND/IDE Contacts

Questions about medical devices (other than gcp questions)
  • DSMICA Staff Directory
  • Manufacturer's assistance: 800-638-2041
  • Consumer assistance: 888-INFO-FDA
  • Questions about whether a product is subject to IDE regulations: call 240-276-4040
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)
  • 301-827-2000
  • Octma@cber.fda.gov (consumer oriented)
  • Matt@cber.fda.gov (manufacturers's assistance)
  • Questions about whether a product is subject to IND regulations: call 301-827-2000
    
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