REMS – One Year Later

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; March 27, 2008. http://www.fda.gov/cder/regulatory/FDAAA/FR_QA.htm. Accessed January 11, 2009.

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

Segligman P.J. FDA Amendments Act (FDAAA): new regulatory authorities. [presentation]. Royal Danish Embassy Conference; November 4, 2008; Copenhagen. http://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; October 15, 2008. http://www.fda.gov/cder/drug/DrugSafety/OSE_OND_MOA.pdf. Accessed January 11, 2009.

Shane R. Risk evaluation and mitigation strategies: impact on patients, health care providers, and health systems. Am J Health Syst Pharm. 2009; 66(24 suppl 7): S6–12.

Meyer B.M. The Food and Drug Administration Amendments Act of 2007: drug safety and health-system pharmacy implications. Am J Health Syst Pharm. 2009; 66(24 suppl 7):S3–5.

Approved Risk Evaluation and Mitigation Strategies (REMS). US Food and Drug Administration; March 1, 2010. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm. Accessed March 22, 2010.

Medication Guides. US Food and Drug Administration; March 16, 2010. http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm. Accessed March 22, 2010.

FDA Drug Safety Communication. New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs). US Food and Drug Administration; February 18, 2010. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm. Accessed February 24, 2010.

FDA Drug Safety Communication. Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp. US Food and Drug Administration; February 16, 2010. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200297.htm. Accessed February 16, 2010.

Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS). US Food and Drug Administration; December 10, 2009. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm. Accessed March 22, 2010.

Sloan P.A. Opioid risk management: understanding FDA mandated risk evaluation and mitigation strategies (REMS). J Opioid Manag. 2009; 5(3): 131–133.