adverse reactions

What Role Do Regulatory Agencies Play?

Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) play a vital role in monitoring and managing adverse reactions. These agencies require comprehensive data on adverse reactions from clinical trials before approving any medical intervention. They also mandate post-marketing surveillance and may issue warnings, restrictions, or recalls based on the findings. Publicly accessible databases maintained by these agencies allow for transparency in reporting and investigating adverse reactions.

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