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FDA Clarifies Rules for Getting Experimental Drugs
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Drug makers and many patient advocates are pleased with the U.S. Food and Drug Administration's recent effort to shed light on when patients can get experimental drugs outside a clinical trial. But the most vocal critics of current policy are far from mollified by the new effort.
More than 10 years after Congress directed the FDA to establish a way to allow seriously ill patients access to promising—but unapproved—drugs, the agency is in the final stages of setting out rules to formalize what has until now been an informal and not always transparent system for granting access outside clinical trials. In recent years, advocates of more access have gone as far as suing for more control.
The policy represents the FDA's attempt to strike a delicate balance between the wishes of individuals and the needs of society. Through that mechanism, more than 100,000 patients have already received experimental
Going Around the FDA
Old Obstacles
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