Tag: untitled letters

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04/18/2022

Presentation of Risks in DTC Video, HCP Webpage Yields Enforcement Letter for Bausch Health

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10/04/2018

CDER’s Woodcock Says First Amendment Concerns Dampen OPDP Enforcement

01/03/2017

OPDP Cites Two Companies for YouTube Videos Featuring INDs

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12/15/2016

OPDP Sends Two Letters Citing Major Statement Treatment in TV Ad Claims

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09/15/2016

OPDP’s Second Enforcement Letter in Two Weeks Targets Investigational Drug

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07/22/2016

OPDP Issues Just Two Enforcement Letters in First Half of 2016

01/25/2016

OPDP Enforcement Letter Cites Hospira for Omission of Risk in YouTube Video

05/23/2014

OPDP Enforcement Letters Address Omission of Risk Information

07/16/2012

OPDP Issues Seven Enforcement Letters in May and June