safety signals

What is the Role of Regulatory Agencies?

Regulatory agencies, such as the FDA in the United States and the EMA in Europe, play a crucial role in monitoring and evaluating safety signals. These agencies have systems in place to collect data, assess the significance of signals, and determine whether further investigation or action is needed. They may require manufacturers to update product labels, conduct additional studies, or even withdraw products from the market if significant risks are identified.

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