FDA Plans Overhaul Of Over-The-Counter Drug System

Law360, New York (February 21, 2014, 4:52 PM EST) -- The U.S. Food and Drug Administration on Friday signaled its intention to overhaul the process for approving and monitoring over-the-counter drugs, saying the decades-old system has big loopholes and can’t react quickly to new scientific information.

In announcing a two-day meeting next month, the FDA said it’s interested in tweaking OTC approvals so they more closely resemble the pathway for prescription drugs — an idea that brought immediate resistance from the consumer products industry.

“We believe that the OTC drug review needs a critical examination at...
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