Category: Regulatory/FDA

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OPDP’s Third Enforcement Letter of 2017 Cites Presentation of Risks, Efficacy Claims

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Gottlieb: FDA Has Vital Role to Play in Addressing Opioid Crisis

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OPDP Issues Warning Letter for Omission of Risks, Material Facts

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FDA Study of Promotion Disclosure Needs to Address First Amendment, Other Issues

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Gottlieb Asserts FDA Authority in Considering Opioid Risks

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OPDP Issues First Enforcement Letter of 2017

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Pines: FDA’s Gottlieb Will First Tackle Administrative Issues

Gottlieb Vote Headed to Full Senate

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Gottlieb Is “Known” Entity to Pharma Industry