By Michelle Tarver MD PhD – For five decades, the 1976 Amendments have served as the foundation of a regulatory framework designed to protect patients while advancing innovation. It has ultimately helped to ensure that medical devices are safe, effective, and high-quality for the people who rely on them.
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By Daniel Caños PhD MPH & Michelle Tarver MD PhD – Today’s health care ecosystem is generating richer and more diverse data streams, providing new opportunities to modernize how Real-World Data generates relevant and reliable Real-World Evidence. The FDA is working to provide clearer recommendations and more consistent acceptance of RWE as valid scientific evidence.
By Michelle Tarver MD PhD & Angela Calman MPA – Thirty-five years ago, the U.S. Food and Drug Administration issued an alert that warned health care providers how certain electrically powered hospital beds could harm and even kill children. That was one of our earliest communications about medical device safety.
By Scott Gottlieb, MD, Jeff Shuren, MD, JD, & Michelle Tarver, MD, PhD – Collaboration. It’s a word we use a lot at the FDA — and for good reason. Collaboration is an essential element of many approaches we apply to achieve our public health mission.