FDA Off-Label Policy Under Fire: Court Rulings Pile Up, House E&C Floats New Bill

13 Jun 2016
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Executive Summary

Republican leadership on the House Energy and Commerce Committee is reviving efforts to legislate changes to FDA’s off-label policy. That renewed pressure comes as the courts are increasingly challenging FDA’s ability to bar truthful speech about unapproved indications.

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FDA Off-Label Policy Under Fire: Court Rulings Pile Up, House E&C Floats New Bill

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