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3. Background: FDA's Regulatory Development Timeline

Overview of Registration Interim Final Rule Implementing the Bioterrorism Act

October 10, 2003

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Background: FDA's Regulatory Development Timeline

  • Feb. 3, 2003: FDA and Customs and Border Protection (CBP) published proposed rule with a 60 day comment period
    • FDA received over 350 comments
  • Oct. 10, 2003: FDA and CBP published interim final rule (registration system operational on Oct. 16, 2003)
    
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