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The QMN Weekly Bulletin
Oct. 19, 2012 | Vol. 4 No. 42
OIG to Continue Investigating FDA’s REMS Program in 2013
During the coming year, the HHS Office of Inspector General (OIG) will continue examining the risk evaluation and mitigation strategies (REMS) program and expects to release findings next year, the office says in its fiscal 2013 work plan.
OIG will review drugmakers’ assessments of the program’s efficacy in minimizing risks and it will examine how well the FDA ensures manufacturer compliance.
The OIG began its investigation of the REMS program in 2011.
With the Food and Drug Administration Amendments Act of 2007 barely in the rear view mirror and the new Prescription Drug User Fee Act V to deal with, drug safety, REMS, and pharmacovigilance in the United States are about to undergo significant changes.
Mark your calendar for the Fifth Annual Risk Management and Drug Safety Summit taking place Dec. 3-4, 2012, in Washington, DC.
Be a part of the conversation on the latest issues related to risk and safety, and examine how REMS and drug safety are faring. Register today!
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