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FDA’s Califf Clarifies Real-World Data Use

Sept. 9, 2016, 9:51 PM

It is a “total misfire” to pit randomized controlled trials against the use of real-world evidence as methods for evaluating new medical products for patients, FDA Commissioner Robert M. Califf said Sept. 8.

The commissioner of the Food and Drug Administration was addressing a move to incorporate real-world evidence, or data captured in routine medical care or from the patient directly, into the agency’s regulatory decision-making process. Real-world evidence language appears in both the House-passed 21st Century Cures bill (H.R. 6) and the Senate’s companion medical innovation effort to accelerate the development of new drugs and devices. The final agreement ...

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