The US FDA regulates foods, drugs, cosmetics, medical devices, tobacco, and electronic products that emit radiation.
The FDA is under the Department of Health and Human Services and is headed by the Commissioner for the Food and Drug Administration, who is appointed by the President and approved by the US Senate.
The Office of the Commissioner oversees all components of the body and is responsible for the effective and efficient execution of FDA's mission.
The FDA commissioner office is divided into departments. The Medical Devices and Tobacco Office control the Center for Drug Evaluation and Research, which regulates drugs sold in the United States.
Pharmaceutical active ingredients (API): Pharmaceutical active ingredients are all substances or mixtures of ingredients intended to be used in the manufacture of drugs and converted into active medicinal ingredients during drug manufacturing.
Such substances are intended to have pharmacological activity or other direct effects in the diagnosis, cure, reduction, treatment or prevention of disease or to affect the structure or function of the body.
Medical intermediates: These are materials that are obtained during the synthesis stage of the active pharmaceutical ingredient (API) and must undergo additional molecular change or processing before becoming an API.
Prescription drugs: are human drugs that are safe to use only under the supervision of a licensed doctor.
OTC (Over-the-Counter) Medicines: Medicines made for humans that can be used safely and effectively without a prescription from a licensed doctor.