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Drug, Device Makers Cheer As FDA Punts Off-Label Policy

Law360, New York (January 12, 2018, 5:23 PM EST) -- The U.S. Food and Drug Administration on Friday once again delayed a controversial new policy related to off-label promotion, drawing cheers from drug and device makers that have decried the agency’s approach.

Friday’s move marked the third delay of a new FDA policy for assessing the “intended use” of drugs and devices. The concept looks at whether products are intentionally being promoted for unapproved uses, which can lead to criminal misbranding charges or False Claims Act liability.

In a proposed rule on Friday, the FDA said...
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