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By: John Roth On July 12, I was in Missoula, Montana when Paul Bottomley, 48, was sentenced as a result of his participation in the wholesale marketing of unapproved and misbranded cancer medications. Many Americans may not know Bottomley or … Continue reading →
By: David S. Buckles, PhD, FACC, and Lawrence “Jake” Romanell Disagreements are inevitable in science, medicine – and even life. As part of a regulatory agency committed to public health, the FDA’s medical devices center occasionally confronts scientific and policy … Continue reading →
By: Karen Midthun, M.D. We’ve all read news reports of research achievements that promise exciting and powerful new treatments such as gene therapies to treat diabetes and cell therapies to rebuild failing hearts. These medical products are biologics and may … Continue reading →
By: Dale Slavin, PhD On several occasions, the FDA has asked its expert advisory committees for advice about acetaminophen, which is used to treat pain and fever. Based on this advice and extensive review of the available scientific evidence, the FDA … Continue reading →
