FDA’s Postmarket Evaluations of Drugs That May Pose Safety Risks

OBJECTIVE

The Food and Drug Administration (FDA) is responsible for ensuring the safety of drugs. Once drugs are on the market, the agency reviews reports of adverse drug events and other data to identify what it calls “potential signals of serious risk,” or safety signals. Safety signals suggest there may be a risk to the public associated with use of the drug. FDA evaluates each safety signal to determine the degree of risk and takes regulatory or compliance action when warranted, such as requesting an update to the drug’s safety label or issuing safety alerts to the public. This study will examine FDA’s postmarket evaluations of safety signals, including timeliness and actions taken to protect the public from harm. We will review case files and summary data for safety signal evaluations over a 10-year period and will interview FDA leadership and staff about their decision-making process.

TIMELINE

• September 16, 2024
  Announced
• Today
  Office of Evaluation and Inspections In-Progress
• Est FY2026
  Estimated Fiscal Year for Project Completion

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