FDA Details Pathways For Speedier Drug Approvals

Law360, New York (June 25, 2013, 7:13 PM EDT) -- The U.S. Food and Drug Administration on Tuesday laid out criteria for a quartet of pathways providing speedier approval of medications designed to address unmet needs for serious conditions, building on similar guidance issued recently for medical devices.

Increased attention has been paid in recent years to filling in the gaps in the nation's medicine chest, and the FDA signaled its enthusiasm by taking the somewhat unusual step of penning a blog post about Tuesday's guidance document.

In addition to three older pathways — fast-track, accelerated...
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