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Regulatory focus theory (RFT) is a theory of goal pursuit [1]: 444 formulated by Columbia University psychology professor and researcher E. Tory Higgins regarding people's motivations and perceptions in judgment and decision making processes.
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” [1] whose goal was the standardization of medical device regulation across the world.
It requires the FDA to establish an Office of the Chief Scientist to: (1) oversee, coordinate, and ensure quality and regulatory focus of FDA intramural research programs; (2) track and coordinate intramural research awards made by each FDA center or science-based office; (3) develop and advocate for a budget to support intramural research; (4 ...
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 ...
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 person's regulatory mode is correlated with regulatory fitness.They display their optimal level of performance in addition to valuing the end goals. In Avnet and Higgin's study (2004), the participants paid more for the book-light when their decisions were based on their regulatory orientation—either locomotion or assessment. [3]
Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare applications (e.g., diagnostic or therapeutic purposes).
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 ...