The FDA operates a robust system of post-market surveillance and risk assessment programs to uncover adverse drug reactions and medication errors not detected during drug development. Through analyzing reports of adverse events—issues patients face after drug intake, irrespective of causality—the FDA evaluates if these events are drug-related. CDER utilizes these reports, alongside other safety data, to monitor approved drugs and biologic products. When new safety concerns arise, the FDA conducts thorough reviews before deciding on appropriate actions. Understanding the difference between adverse events and adverse drug reactions is vital: adverse events encompass any unexpected medical occurrences, while adverse drug reactions denote harmful responses caused by medication.

Read more about the role of CDER and the FDA in post-market surveillance by clicking here.

References

  1. Research, C. F. D. E. A. (2024, April 3). Understanding CDER’s postmarket safety surveillance programs and public data. U.S. Food And Drug Administration. https://www.fda.gov/drugs/cder-conversations/understanding-cders-postmarket-safety-surveillance-programs-and-public-data

Disclaimers

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