The Food and Drug Administration Amendments Act of 2007: Drug safety and health-system pharmacy implications

Meyer, Brian M.
December 2009
American Journal of Health-System Pharmacy;12/15/2009, Vol. 66 Issue 24, pS3
Academic Journal
The article focuses on the drug safety provisions of the Food and Drug Administration Amendments Act (FDAAA) of 2007 like the risk evaluation and mitigation strategies (REMS) and the significance on pharmacists. It mentions that FDAAA amends the Federal Food, Drug and Cosmetic Act and authorize the U.S. Food and Drug Administration (FDA) to demand post marketing studies and clinical trials on human drugs and REMS. It notes that standardization ensures drug safety with the knowledge on risks.


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