Awareness of Risk Evaluation and Mitigation Strategy Program for New Drugs

Lee L.Y. , Kortepeter C.M. , Willy M.E. , Nourjah P. Drug-risk communication to pharmacists: assessing the impact of risk-minimization strategies on the practice of pharmacy. J Am Pharm Assoc (2003). 2008; 48(4): 494–500.

Questions and answers on the Federal Register notice on drugs and biological products deemed to have risk evaluation and mitigation strategies. US Food and Drug Administration Website.www.fda.gov/cder/regulatory/FDAAA/FR_QA.htm. Updated March 27, 2008. Accessed January 11, 2009.

Office of Surveillance and Epidemiology; US Food and Drug Administration. An overview of RiskMAPs. www.docstoc.com/docs/573628/An-Overview-of-RiskMAPs. Published June 25, 2007. Accessed January 10, 2009.

Post-approval frequently asked questions (FAQ). Pharmaceutical Product Development, Inc, Web site. www.ppdi.com/services/post_approval/faq.htm. Published 2009. Accessed January 11, 2009.

Segligman P.J. FDA Amendments Act (FDAAA): New regulatory authorities [presentation]. Paper presented at: Royal Danish Embassy Conference; November 4, 2008; Copenhagen, Denmark. www.ambwashington.um.dk/NR/rdonlyres/60B9CA25-FF37-4B89-93D7-959D9F9F24BB/0/915FDAAmendmentsActandNewRegulatoryAuthorityPaulSeligman.ppt. Accessed January 10, 2009.

Jenkins J. , Dal Pan G. Memorandum of agreement between the Office of New Drugs and the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research. US Food and Drug Administration Web site. www.fda.gov/cder/drug/DrugSafety/OSE_OND_MOA.pdf. Published October 15, 2008. Accessed January 11, 2009.

Approved risk evaluation and mitigation strategies (REMS). US Food and Drug Administration. www.fda.gov/cder/drug/DrugSafety/REMS.htm. Published October 28, 2008. Accessed January 11, 2009.