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The Food and Drug Administration, whose decisions shape roughly one-fifth of the U.S. economy, is undergoing a consequential shift. Current agency leaders are signaling tougher evidentiary standards for vaccines, including the annual flu shot, while simultaneously proposing accelerated pathways for certain drugs and medical devices with less pre-market data than historically required. Rebecca Adams, WP Intelligence lead health care analyst, and Dr. Robert Califf, former FDA commissioner and instructor at Duke University School of Medicine, break down last year’s changes at the FDA, the effects of a selective emphasis on speed, and how health care firms are re-evaluating their investments in response. The briefing was held on January 31 and was moderated by Luiza Savage, editorial director of WP Intelligence.