The Food and Drug Administration (FDA) is the federal regulatory agency of the United States responsible for protecting public health by ensuring the safety, efficacy, and quality of human drugs, biologics, medical devices, vaccines, and food products. In the biopharmaceutical context, the FDA oversees the regulatory approval of drug substances and drug products through submissions such as Investigational New Drug (IND) applications, Biologics License Applications (BLAs), and New Drug Applications (NDAs), and enforces compliance with cGMP regulations through facility inspections.
