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Drug industry is Nervous about Joshua Sharfstein as Obama's pick for FDA deputy
President Obama's pick to lead the Food and Drug Administration has been appreciated by Food, pharmaceutical and medical device groups but his selecti...
Drug Makers Say FDA Safety Focus Is Slowing New-Medicine Pipeline
Nearly four years after Merck & Co. yanked the painkiller Vioxx off the market, beleaguered pharmaceutical-industry executives say they are facing a t...
Drug Safety Information–FDA’s Communication to the Public
This document provides guidance on how FDA is developing and disseminating information to the public regarding important drug safety issues, including...
Drug safety recalls linked to tight approval deadlines at FDA
Vioxx, Bextra, Rezulin, Baycol. Looking at drugs yanked off the market, Harvard researchers found a disturbing pattern: Medicines approved right on de...
Drug Tied to China Had Contaminant, F.D.A. Says
Federal drug regulators said Wednesday that a critical blood thinner that had been linked to at least 19 deaths and whose raw components were produced...
Drug Warning Labels Should Include FDA Ties to Big Pharma
Ninety-two percent of FDA advisory meetings in the last decade included a member with financial ties to drug companies. A look at how that affects the...
Drug-coated stents merit new studies, FDA says
More than a year after the multibillion-dollar market for drug-coated stents was first roiled by concerns about blood clots forming in the devices, th...
Drugmaker Actavis restarts its plant after FDA's consent
Drugmaker Actavis Totowa L.L.C. started making two strengths of Oxycodone at one of its three North Jersey facilities that was closed last year becaus...
Drugmakers Didn't Begin 1,044 Promised U.S. Studies
Drugmakers haven't made progress in starting studies that they promised to conduct after their products were approved by U.S. regulators, according to...
Drugmakers Lobby for Obama to Name Woodcock as FDA's Chief
Drugmakers are lobbying for President-elect Barack Obama to name Janet Woodcock, a senior official of the Food and Drug Administration, as the agency'...


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