FDA Blocked from Bringing Action Against ‘Truthful’ Off-label Claims

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FDA Blocked from Bringing Action Against ‘Truthful’ Off-label Claims

Dennis Tosh

FDA Enforcement Manual

August 20, 2015 at 12:32 PM EST

In what has been called a “highly significant” ruling, the U.S. District Court for the Southern District of New York Aug. 7 blocked the FDA from making good on its threat to bring misbranding charges against the manufacturer of a prescription drug because the company sought to make several truthful statements to doctors relating to off-label use of the product (Amarin Pharma,... Read More

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FDA Blocked from Bringing Action Against ‘Truthful’ Off-label Claims

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