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U.S. Department of Health and Human Services


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PPT Slide - Reporting

  • FDA program initiated in 1993
  • Four main goals of the program
    • Increase awareness of medical product (drug) induced disease and the importance of reporting
    • Clarify what should (and should not) be reported
    • Facilitate the ease of reporting
    • Provide feedback to health professionals about new safety issues
  • www.fda.gov/medwatch or 1-800-FDA-1088



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