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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 affairs also has a very specific meaning within the healthcare ...
Regulatory science is the scientific and technical foundations upon which regulations are based in various industries – particularly those involving health or safety. . Regulatory bodies employing such principles in the United States include, for example, the FDA for food and medical products, the EPA for the environment, and the OSHA for work sa
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
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 ...
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 ...
Administrative law of the United States. 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 ...
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