Tag: FDA enforcement

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OPDP Untitled Letter Cites False, Misleading Claims about Efficacy, Risk Presentation for Obesity Drug

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OPDP Issues Enforcement Letter for Investigational Drug Promotion

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FDA Applies Increased Scrutiny to Nutritional Supplements Claiming Pain Relief

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CDRH Issues Warning Letter for Device Cancer Diagnosis Claims in Brochures, on Website

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OPDP Cites Lack of Risk Information in Second Warning Letter of 2018

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Exhibit Booth and Webpage Misbrand IND, OPDP Says in Enforcement Letter

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False/Misleading Risk, Efficacy Claims in Online Video Cited in OPDP Enforcement Letter to Pfizer

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CBER’s APLB Issues First Enforcement Letter Since 2015 for Misleading Efficacy Claims

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First 2018 OPDP Enforcement Letter Targets Exhibit Booth for Opioid