Which agency primarily regulates the approval of antibiotics?

The agency that primarily regulates the approval of antibiotics is the Food and Drug Administration (FDA). The FDA is responsible for ensuring that all drugs, including antibiotics, are safe and effective for use before they can be marketed to the public. This process involves rigorous evaluation of clinical trial data, assessment of manufacturing practices, and ongoing oversight of the drug's use once it is on the market.

The FDA also sets the standards for the labeling and advertising of antibiotics, ensuring that healthcare providers and patients receive accurate information about the medication's uses, risks, and benefits. This regulatory framework helps to protect public health by ensuring that antibiotics meet high safety and efficacy standards before they reach consumers.

While the CDC (Centers for Disease Control and Prevention) plays a crucial role in monitoring antibiotic use and resistance patterns, and the WHO (World Health Organization) focuses on international health and disease management, they do not have the authority to approve medications. The National Institute of Mental Health (NIMH) is primarily concerned with mental health issues and does not regulate medications like antibiotics.