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OFF-LABEL PROMOTION IS UNLIKELY TO PROVIDE INFORMATION BENEFIT TO PHYSICIANS, FDA's TEMPLE SAYS; SINGLE PIVOTAL STUDIES ARE "NOT CHEAPER" AND "HIGH RISK"

Executive Summary

A relaxation of FDA's prohibition on the promotion of off-label uses of pharmaceuticals is unlikely to improve the practice of medicine, FDA Office of Drug Evaluation I Director Robert Temple, MD, contended during the Third Annual Princeton Drug Development Conference in Princeton, N.J. May 5.
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PS026208

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