What agency regulates the approval and safety of new drugs in the U.S.?

The Food and Drug Administration (FDA) is the agency responsible for regulating the approval and safety of new drugs in the United States. This agency's primary role includes ensuring that all pharmaceutical products meet specific safety, efficacy, and quality standards before they can be marketed to the public. The FDA conducts thorough evaluations of clinical trial data submitted by drug manufacturers, which provides insights into how the drug works, its potential side effects, and its overall safety profile.

The importance of the FDA’s role cannot be overstated, as it protects public health by ensuring that new drugs are rigorously tested and monitored. This includes both pre-market evaluations and ongoing post-market surveillance to track drug performance and emerging safety issues once a drug is on the market.

In contrast, the Department of Health and Human Services oversees public health initiatives and research, the Centers for Disease Control and Prevention focuses on disease prevention and control, and the National Institutes of Health primarily supports medical research. While these organizations play vital roles in health and medical research, they do not have the authority to approve and regulate drugs as the FDA does.