Which agency is responsible for regulating drugs and biologics in the United States?

The Food and Drug Administration (FDA) is the agency tasked with regulating drugs and biologics in the United States. Its responsibilities encompass ensuring the safety and efficacy of pharmaceuticals and biological products before they can be marketed to the public. The FDA evaluates new drugs and biologics through a rigorous review process that includes assessing clinical trial data to determine if a product meets the established standards for use. This agency also monitors products after they enter the market, managing recalls and safety communications when necessary.

In contrast, the National Institutes of Health (NIH) primarily focuses on biomedical research and public health, serving as a key funding source for health-related studies rather than a regulatory body. The Centers for Disease Control and Prevention (CDC) is dedicated to public health and safety, particularly in disease control and prevention, but it does not have regulatory authority over drugs and biologics. The U.S. Patent and Trademark Office handles intellectual property issues related to patents and trademarks, which is not directly related to the regulation of drugs or biologics. Thus, the FDA stands out as the definitive regulatory authority in this area.