Tag: Warning Letter

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OPDP Warning Letter: Omission of Risk Info in DTC Print Ad/Display Banners Misbrands ED Drug

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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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Bad Ad Program Yields Two OPDP Enforcement Letters on Risk, Safety Information

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OPDP Enforcement Letter Grand Total for 2017: Five

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

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OPDP Issues Warning Letter for Omission of Risks, Material Facts