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J Pain Palliat Care Pharmacother · Jun 2012
Shared risk evaluation mitigation strategy for all immediate-release transmucosal fentanyl dosage forms.
- Food And Drug Administration, Public Health Service, U.S. Department Of Health And Human Services.
- J Pain Palliat Care Pharmacother. 2012 Jun 1; 26 (2): 123-6.
AbstractThe Food and Drug Administration approved a single shared Risk Evaluation Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl dosage forms in December 2011. This report describes the goals, elements, and restricted distribution system of the REMS designed to reduce risk of abuse, misuse, addiction, and overdose with the drugs. Questions and answers about REMS also are presented. The U.S. Food and Drug Administration (FDA) announced a shared REMS for all immediate-release transmucosal fentanyl dosage forms on December 29, 2011, to become effective in March 2012. That announcement is accessible at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm285345.htm. Concurrently the FDA posted a series of questions and answers on this shared REMS at: http://http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm284717.htm. Both documents are in the public domain.
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