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Regulatory affairs. Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory ...
Regulatory agency. A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous dominion over some area of human activity in a licensing and regulating capacity. These are customarily set up to strengthen safety and standards, and ...
Chief compliance officer. The chief compliance officer (CCO) is a corporate executive within the C-suite responsible for overseeing and managing regulatory compliance issues within an organization. The CCO typically reports to the chief executive officer or the chief legal officer.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
The Office of Information and Regulatory Affairs (OIRA / oʊˈaɪrə / oh-EYE-rə) is a division within the Office of Management and Budget under the Executive Office of the President. OIRA oversees the implementation of government-wide policies in, and reviews draft regulations under, Executive Order 12866, the Paperwork Reduction Act, and the Information Quality Act.
One definition of “regulatory science” is the science of developing new tools, standards and approaches to evaluate the efficacy, safety, quality and performance of medical products in order to assess benefit-risk and facilitate a sound and transparent regulatory decision-making.
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