Regulator's Role

In the US, the FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that merit radiation. In other parts of the world, there are similar regulators with similar goals such as the European Medicines Agency in Europe.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines to maintain and improve their health.

The FDA uses a broad range of methods to communicate drug safety information to the public. Certain forms of communication are targeted to specific audiences (for example healthcare providers or patients). Others are directed toward more than one group to ensure widespread communication of information about important drug safety issues, including emerging drug safety issues.

A specific example of this communication is FDA’s MedWatch alert program. This program provides timely new safety information on human drugs, medical devices, vaccines and other biologics. The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare providers and patients.

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