The proposal is part of ongoing talks about reauthorization of the fee system pharmaceutical companies use to fund FDA reviews. The plan proposes to allows drug companies to conduct shorter trials that are based on a measured effect of a drug — such as tumor shrinkage — instead of a clinical outcome.
Agency officials told Bloomberg that the agency already has several fast-track options in place, and 75 percent of rare-disease treatments since 2006 have been approved based on limited trials.
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