FDA Authority To Require Rx Label Changes Would Be "Helpful," Kweder Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Officer of New Drugs Deputy Director Kweder tells Senate Health Committee that the agency lacks the ability to dictate the contents of drug labeling, but that the power to do so "would be very helpful." Kweder notes it took over a year to negotiate the addition of cardiovascular risk information to Merck's Vioxx.
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