Category: Regulatory/FDA

CHC_FDA-Regulatory Images1

10/19/2018

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

CHC_FDA-Regulatory Images1

10/04/2018

CDER’s Woodcock Says First Amendment Concerns Dampen OPDP Enforcement

CHC_FDA-Regulatory Images1

08/30/2018

EstroGel Sell Sheet Efficacy Claim Cited in 4th OPDP Enforcement Letter of 2018

CHC_general1

08/20/2018

FDA Studying Extent of Risk Information in DTC Print Ads

CHC_offLabel

08/13/2018

FDA Finalizing Study of Disclosure Effectiveness in Drug Promotion

CHC_FDA-Regulatory Images1

07/31/2018

FDA Cracks Down on Deceptive Claims for “Vaginal Rejuvenation” Procedures

CHC_general1

07/11/2018

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

CHC_FDA-Regulatory Images1

07/02/2018

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

CHC_FDA-Regulatory Images1

06/14/2018

FDA Final Guidance Documents on Communication Issues Improve Clarity