Writing for the Annals of Internal Medicine, Rita F. Redberg, MD, has taken FDA to task for insufficient rigor in its Premarket Approval (PMA) supplement approvals. Redberg is Professor of Medicine in the Women’s Cardiovascular Services Division of Cardiology, at the University of California, San Francisco, and wrote, along with coauthor Sarah Zheng, “Premarket Approval Supplement Pathway: Do We Know What We Are Getting?” which was published online.
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