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Article
June 26, 1981

Postmarketing surveillance vs phase III

JAMA. 1981;245(24):2485-2489. doi:10.1001/jama.1981.03310490007004

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Abstract

The time required to get a new drug onto the US market has virtually doubled in the past 15 years, and nothing short of a "radical" rearrangement of the approval process is going to reverse that trend.

That is the view of William M. Wardell, MD, director of the Center for the Study of Drug Development, University of Rochester (NY) Medical Center. Wardell is the originator of the controversial "drug lag" hypothesis that contends that the United States is lagging behind other developed countries in introducing therapeutic drugs into medical practice.

Speaking to a national conference on drug prescribing held at New York's Mount Sinai School of Medicine, Wardell said that one way around the "logjam" might be to eliminate phase III of the Investigational New Drug (IND) process—that which has to do with collection of large masses of long-term clinical data—and rely instead on improved and intensified postmarketing surveillance

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