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June 4, 1982

Regulation and Development of New Drugs

JAMA. 1982;247(21):2995-2998. doi:10.1001/jama.1982.03320460091039

In a field as rapidly evolving as clinical pharmacology, it may appear trite to observe that 1981 was an important year. Yet, from the standpoint of new trends in drug regulation as well as advances in therapeutics, the preceding year was indeed noteworthy.

Developments in Drug Policy 

Food and Drug Administration.—  The 75th anniversary of the enactment of the first Federal Food and Drug Act and the subsequent establishment of the FDA were celebrated in 1981. Retrospectively, few who supported that original law, including the American Medical Association, could have predicted that it would lead to our present, complex system of drug regulation and development. Although there are many who now are concerned by what they perceive as overregulation, there are scarcely any who would argue against the need for some type of drug regulation. The remarkable technological advancements during the past 75 years have made clinical therapeutics too sophisticated