Tag: Untitled Letter

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12/01/2019

Promotion of IND for Brain Cancer Treatment Prompts OPDP Enforcement Letter

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10/07/2019

OPDP Cites Risk Presentation Issues in YouTube Video, Email in New Enforcement Letters

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08/05/2019

Latest OPDP Enforcement Letters: Don’t Omit or Distract from Risk Information

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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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10/19/2018

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

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08/30/2018

EstroGel Sell Sheet Efficacy Claim Cited in 4th OPDP Enforcement 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

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02/23/2018

First 2018 OPDP Enforcement Letter Targets Exhibit Booth for Opioid