Category: Regulatory/FDA

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03/07/2018

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

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02/23/2018

First 2018 OPDP Enforcement Letter Targets Exhibit Booth for Opioid

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01/24/2018

OPDP Enforcement Letter Grand Total for 2017: Five

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01/15/2018

FDA Calls for Additional Comment on Revised Intended Use Language

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12/22/2017

FDA To Study Consumer, HCP Ability to Spot Deceptive Drug Ads

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12/15/2017

FDA Finalizes Guidance on Name Placement, Size and Prominence

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11/30/2017

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

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10/30/2017

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

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09/08/2017

OPDP Issues Warning Letter for Omission of Risks, Material Facts