Detecting Unexpected Adverse Events: Gardasil Study Aims For Holy Grail
TreeScan methodology for finding unsuspected adverse reactions enters final stages of testing using Merck’s HPV vaccine Gardasil as guinea pig; statistical approach could help “maximize” Sentinel’s potential, FDA says.
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While the statutes at issue in the case, which revolved around banning just one use of a medical device, do not govern drugs, experts on FDA law said the decision addressing a product’s intended use and regulation of the practice of medicine could have some impact on the agency’s Rx oversight powers.
Acting US FDA Commissioner says it is standard for the Office of Neuroscience to issue broad labels like the one originally granted to Biogen’s new Alzheimer’s drug, but the agency declined to answer follow-up questions on such a policy. Woodcock continued to defend Aduhelm’s accelerated approval but conceded that the process might have been improved in an unusually tense public appearance.