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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

FDA’s Role in Postmarketing Drug Safety Surveillance

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Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Tue, 2/8/22: 12:00 AM EST
Ends On: Tue, 12/31/24: 12:00 AM EST
Type: Enduring Material
Credits: 1
Description: This webinar provided an overview on how the FDA conducts postmarketing drug safety surveillance at the Center for Drug Evaluation and Research (CDER). We discussed how adverse event reports are collected, analyzed, and communicated to the public.
Objectives:
  • Describe FDA’s drug safety surveillance system at the Center for Drug Evaluation and Research (CDER).
  • Explain the MedWatch Program and how you can have an impact on signal detection.
  • Discuss how adverse event reports are collected and analyzed.
  • Demonstrate how safety findings are communicated to the public.
Additional Information: Review the Activity Announcement for additional details: Announcement Form
Additional Resources: FDA'sRoleinPostmarketingDrugSafetySurvillance_Slides