Tag: FDA enforcement

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09/25/2019

FDA Amps Up Foreign Inspections Under Pressure to Bend on Opposition to Drug Importation

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09/09/2019

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

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06/19/2019

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

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04/30/2019

OPDP Issues Enforcement Letter for Investigational Drug Promotion

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03/28/2019

FDA Applies Increased Scrutiny to Nutritional Supplements Claiming Pain Relief

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02/28/2019

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

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11/02/2018

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

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07/11/2018

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

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07/02/2018

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