FDA Advises Researchers On Drug Evaluating

Published: Jan 12, 2006

Concerned by a system in which more than nine out of 10 experimental drugs fail when tested in humans, the Food and Drug Administration issued suggestions Thursday on how researchers can more efficiently evaluate the promise of new laboratory discoveries. The vast majority of drug candidates fail once they're tested on humans, invariably for safety or efficacy reasons difficult to predict based on initial experiments done in test tubes and on animals. That can waste significant amounts of time and money, slowing the process of developing new drugs. The goal of the new approaches being floated by the FDA is to guide researchers on methods of identifying early-on those drug candidates that are most likely to succeed once early testing in humans gets under way. Those so-called exploratory investigational new drug studies typically involve very limited numbers of subjects given small amounts of a drug for brief periods. The new advice also offers approaches for safely producing the small batches of drugs needed for initial tests. Given the limited scope of early trials, the manufacturing requirements should be less burdensome than they are for drugs already on the market, according to the FDA. The suggestions are part of what the regulatory agency calls its critical path initiative, which refers to the journey a drug takes from laboratory to patient. The initiative, introduced in 2004, aims to improve the efficiency and safety of the development of drugs and other medical products.

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