Have PDUFA Dates Increased Safety Issues? Study Says Yes, FDA Says No
FDA is preparing to rebut an analysis published in the New England Journal of Medicine March 27 suggesting that new molecular entities approved close to review deadlines under the Prescription Drug User Fee Act are more likely to suffer post-market safety problems
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DURHAM, N.C. - Any surge in FDA post-market safety actions stems from the rapid approval of AIDS drugs during the 1990s, and not errors made as a result of review time constraints created by user fee deadlines, Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter maintained June 23
The International Fragrance Association North America took a break from its higher-stakes advocacy work Nov. 1 to give lawmakers and congressional staffers a "scent experience." Perfumers from six of the group's biggest members were on hand with "Scents of Home," joined by Monell Center researchers to educate attendees on the mechanics of scent and the important role it plays in people's lives.