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Off-label Ruling’s Potential Fallout Is “Terrifying,” FDA’s Temple Says

 
• By Brenda Sandburg

If firms could promote drugs for uses not backed by well-controlled studies, it would be “a nightmare,” Temple says; AEI’s Scott Gottlieb suggests the agency might try to regulate how medicines are prescribed.

FDA’s Robert Temple envisions a nightmare situation if the Caronia ruling enables companies to promote drugs for uses that are not supported by well-controlled clinical trials.

Temple, deputy director for clinical science in the Center for Drug Evaluation and Research, discussed the decision at the FDA/CMS...

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More from North America

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• By Malcolm Spicer

The FDA included storage and handling instructions common in labeling in its approval announcement, suggesting concerns remain about the potential for NDMA to form after products are distributed.

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• By Michael McCaughan

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• By Derrick Gingery

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