Who is the FDA?
In the United States, the Food and Drug Administration (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 emit radiation. In other parts of the world, similar regulators exist with similar goals, such as the European Medicines Agency.
The roles of the FDA also include the advancement of public health by helping to speed innovations that make medicines more effective, safer and more affordable, and by helping members of 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, health care 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 health care providers and patients.
Regulatory authorities worldwide, including the FDA, monitor the benefit/risk balance of marketed drugs, medical devices and cosmetic products in accordance with each country's local or regional laws and regulations.
Based on these activities, regulatory authorities may take actions such as requesting that drug or medical device companies update the information in the product label or conduct additional risk assessment or minimization activities. This may include additional research to evaluate a safety risk or communications to health care providers/consumers to bring attention and emphasize the new information included in the updated product label.
In some instances, regulatory authorities may decide to directly communicate with the public and with health care providers.