Catching Biopharmaceutical Sponsors by Surprise

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Pharmaceutical Executive

The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects.

The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects. During an update on The Future of FDA’s Drug Safety Program, Andrew C. von Eschenbach stated, “The full magnitude of some potential risks does not always emerge during the mandatory clinical trials conducted before approval.”

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In this Applied Clinical Trials article, Moe Alsumidaie discusses FDA’s post-marketing surveillance programs, and how biopharmaceutical sponsors can work with the FDA to identify unreported Adverse Events (AEs).