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10. U.S. Agent (cont.)

Overview of Registration Interim Final Rule Implementing the Bioterrorism Act

October 10, 2003

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 BT Act Registration IFR Overview slide 10

U.S. Agent (cont.)

  • The U.S. agent acts as a communications link between FDA and the facility for both routine and emergency communications, unless the facility opts to designate a different emergency contact
  • Having one U.S. agent for registration purposes does not preclude a foreign facility from having multiple agents for other purposes (E.g., sales)
    
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