How Much Do Physicians Really Know About FDA Drug and Device Regulation?

MedPage Today January 28, 2024
Sanket S. Dhruva, MD, MHS, Aaron S. Kesselheim, MD, JD, MPH, and Rita F. Redberg, MD, MSc

— More education is clearly needed

Medications, from blood pressure control to chemotherapy, and medical devices, from hip replacements to heart valves, represent the backbone of healthcare. Ubiquitous in everyday clinical medicine, drugs and devices are only available for use if they have received the FDA’s stamp of approval. Most people — including physicians — expect that FDA approval means assurance of effectiveness and sufficient safety.

However, in the modern era, novel approaches to regulation around certain drugs and devices means that the level of evidence supporting different new products can vary quite substantially. Are physicians aware of these changes in regulation?

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