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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
Regulation in the United States had its origins in 1906 with the enactment of the Food and Drugs Act.This initial step towards regulatory oversight was further strengthened in 1938 with the implementation of the Federal Food, Drug, and Cosmetic Act, prompted by the tragic incident involving Elixir sulfanilamide in 1937, which led to numerous fatalities.
The Regulatory Review is an online, daily publication devoted to coverage of regulatory news, analysis, and commentary. It is produced under the auspices of the Penn Program on Regulation and operated by students at the University of Pennsylvania Law School .
Obligational awareness refers to the ability of the organization to make itself aware of all of its mandatory and voluntary obligations, namely relevant laws, regulatory requirements, industry codes and organizational standards, as well as standards of good governance, generally accepted best practices, ethics and community expectations.
Investigational New Drug (IND) Application Process Center for Drug Evaluation and Research, Food and Drug Administration. ICH Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance. BROKEN LINK; Troetel, W.M.: Achieving a Successful US IND Filing (1) The Regulatory Affairs Journal. 6: 22–28, January 1995.
Policy proposals must also quantify the regulatory burden on individuals, businesses, and community organisations under the viable options. Following announcement of a decision, the impact analysis used to support Government decision-making is published online, as is OIA's assessment of the quality of that analysis and the processes undertaken ...
A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous jurisdiction over some area of human activity in a licensing and regulating capacity.
Federally funded research and development centers (FFRDCs) are public-private partnerships that conduct research and development for the United States Government.Under Federal Acquisition Regulation § 35.017, FFRDCs are operated by universities and corporations to fulfill certain long-term needs of the government that "...cannot be met as effectively by existing in-house or contractor resources."