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Restoring FDA’s Premarket Review Powers
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Restoring FDA’s Premarket Review Powers
The U.S. Food and Drug Administration (FDA) is tasked with ensuring the safety of at least $3.9 trillion of food, drugs, and devices. Increasingly, however, experts have linked failures in FDA’s premarket oversight processes to public health crises. As the primary gatekeeper of these products, does FDA hold robust enough premarket review powers to fulfill its broad mandate? In a recent article, Daniel G. Aaron, an associate professor of law at U…
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