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Pharmaceuticals / Regulatory Affairs / Commercial Operations

Cures Act Left Drug-Device Distinction Murky, Panel Says

June 15, 2017
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The 21st Century Cures Act represents a “missed opportunity” to clarify the distinction between a drug and a device and improve transparency, according to experts at a June 8 combination products conference sponsored by FDAnews in Washington D.C.

The act prohibits the FDA from classifying a product as a drug solely because it involves some form of chemical reaction — a provision that appears to confuse a product’s primary intended purpose with its primary mode of action, said Suzanne O’Shea, director of Navigant Consulting, speaking as part of a panel discussion on the Cures Act’s impact on the combination product review process.

The law should have established a clear definition of where drugs begin and devices end, she said: “If the question is ‘where should we draw line between drugs and devices?’ [the Cures Act] doesn’t do that,” she said.

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