The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and
medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.
The mission of the Office of Regulatory Affairs (ORA) is to protect consumers/patients and enhance public health by ensuring timely access to safe, quality FDA-regulated products. To view our ORA Vision, Mission, and Values please visit: https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs.
The Office of Regulatory Affairs (ORA) is at the forefront of building a public health safety net for today’s complex, global regulatory environment. ORA professionals work in a range of program areas and locations, with 227 offices and 12 laboratories throughout the United States. As the lead office for all FDA field activities, ORA serves as the agency’s direct connection with regulated industry through a) inspections of firms and plants producing FDA-regulated products, b) investigations of consumer complaints, emergencies and criminal activity, c) enforcement of FDA regulations, d) sample collection and analysis, and e) review of imported products.
The Office of Regulatory Science (ORS) provides strategic leadership, coordination, and expertise to the Associate Commissioner for Regulatory Affairs (ACRA), Deputy Associate Commissioner for Regulatory Affairs (DACRA) and other ORA senior leaders on scientific issues related to policy and regulations.
The Office of Human & Animal Food Laboratory Operations (OHAFLO) advises the ORS on scientific issues related to human and animal food laboratory operations and provides strategic leadership and support for high quality, collaborative, scientific activities that advance regulatory science and address important public health issues concerning the Food and Drug Administration (FDA) regulated products, including their evaluation, quality, safety, and effectiveness.