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5. Regulatory Development Timeline (cont.)

Overview of Registration Interim Final Rule Implementing the Bioterrorism Act

October 10, 2003

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 5

Regulatory Development Timeline (cont.)

  • FDA also is developing two additional rules:
    • Section 306: Establishment and Maintenance of Records
    • Section 303: Administrative Detention
  • Goal: by December 12, 2003, publish final rules implementing these two provisions and hold satellite downlink meeting shortly after
    
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