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The Regulatory Affairs Journal Pharma (RAJ Pharma) is an English language international pharmaceutical information and analysis service published by Informa plc.First published as a monthly print magazinel in 1992, it includes articles covering worldwide regulatory affairs within the pharmaceutical industry.
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.
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 ...
Drug Design, Development and Therapy; Drug Development and Industrial Pharmacy; Drug Discovery Today; Drug, Healthcare and Patient Safety; Drug Safety; Drug Metabolism Reviews; Drug Testing and Analysis; European Heart Journal - Cardiovascular Pharmacotherapy; European Journal of Pharmaceutical Sciences; European Journal of Pharmaceutics and ...
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 ...
The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma, [43] and in 2004 by David Healy in evidence to the House of Commons Health Committee, [44] for having undergone regulatory capture, i.e. advancing the interests of the drug companies rather than the interests of the public.
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may ...
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.