Growth of REMS challenges FDA, stakeholders

Traynor, Kate
August 2010
American Journal of Health-System Pharmacy;8/1/2010, Vol. 67 Issue 15, p1221
Academic Journal
The article reports that the increase in risk evaluation and mitigation tactics (REMS) poses a challenge to the U.S. Food & Drugs Administration (FDA). It states that the REMS and medication guide (MedGuide) are necessary for the FDA to ensure the efficiency of unapproved drugs as well as its adverse effects. However, Claudia Karwowski of FDA Office of Surveillance and Epidemiology says at the annual Drug Information Association meeting in Washington, D.C. that REMS is an administrative burden.


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