Objectives and achievements of regulations in the USA
The single most important function of a regulatory system is to assure the safety of drugs. The combination of careful animal toxicology, diligent clinical evaluation and adverse event reporting after marketing has markedly reduced the risk of catastrophic events associated with drug usage.
The Drug Efficacy Study Implementation (DESI) Review of drags marketed prior to 1962, which assessed efficacy, had the effect of rationalizing the drug market place and introducing honest labelling and scientific integrity to all the drugs that passed the review. However, the true importance of the requirement for effectiveness of a new drug to be demonstrated by adequate and well controlled trials, was not fully realised at the time of the 1962 Amendments.
The Institutional Review Board system has contributed significantly to maintaining the credibility of clinical research.
The impact on drug regulation of the FDA advisory committee system, with open, well organized meetings, has been substantial.
The accomplishments of the regulatory process in the United States, have been achieved at high cost, in terms of patent life erosion, expensive clinical trials, and extensive documentation requirements. However, the academic community, the drug industry and the Food and Drug Administration now operate in an atmosphere of mutual interest and respect.
KeywordsAdverse Event Reporting Drug Regulation Drug Industry Committee System Inform Consent Requirement
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