Health Affairs January 11, 2024
Sanket S. Dhruva, Aaron S. Kesselheim, Steven Woloshin, Robin Z. Ji, Zhigang Lu, Jonathan J. Darrow, and Rita F. Redberg

Abstract

Physicians’ knowledge of Food and Drug Administration (FDA) approval processes is important in informing clinical decisions and patient discussions. Among a randomly selected national sample of 509 internists, cardiologists, and oncologists, 41 percent reported moderate or better understanding of the FDA’s drug approval process, and 17 percent reported moderate or better understanding of the FDA’s medical device approval process. Nearly all physicians thought that randomized, blinded trials that met primary endpoints should be very important factors required to secure regulatory approval. Also, nearly all...

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