FDA's Woodcock To Testify Before Senate Health Committee March 3
This article was originally published in The Pink Sheet Daily
Executive Summary
Janet Woodcock is one of two FDA representatives testifying at two days of hearings on issues related to drug safety; Sandra Kweder will testify March 1. Vertex Pharmaceuticals CEO Joshua Boger will present the pharmaceutical industry's point of view.
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FDA Authority To Require Rx Label Changes Would Be "Helpful," Kweder Says
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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