FDA Details Label Development For Fast-Tracked Drugs

Law360, New York (March 24, 2014, 1:32 PM EDT) -- The U.S. Food and Drug Administration on Monday explained how drugmakers should develop labels for products that receive accelerated approval, describing an array of caveats and revisions that are needed at different stages of product marketing.

In its draft guidance, the FDA discussed the distinct approaches needed when discussing the benefits of fast-tracked drugs that are cleared for sale on the basis of so-called surrogate endpoints. Those measurements look at certain health attributes, such as blood pressure, as opposed to actual health outcomes, such as deaths...
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