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FDA Risk Evaluation and Mitigation Strategies (REMS)
Risk Evaluation and Mitigation Strategies. See the following information from the US Food and Drug Administration (FDA).: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm
See the following information and announcements from the FDA and the White House Office of National Drug Control Policy: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm http://www.whitehousedrugpolicy.gov/prescriptiondrugs/index.html
Just after these recent announcements, the FDA sent a letter to each manufacturer of long-acting and extended-release opioids. The letter detailed the manufacturers' responsibilities under REMS. A template of that...
The FDA letter notified manufacturers of opioids that "The [manufacturers of Opioids] must ensure that training is provided to prescribers who prescribe [their product]...To assure access to [the manufacturer's product]...
The ACCME issued a news release and audio commentary in response to the FDA announcement of the opioids REMS, explaining that accredited CME is well-positioned to deliver this content to...
The FDA wrote, "An outline of the content for this information is described"... and attached an "Appendix A" to the letter which can be found at http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM252179.pdf
The FDA also said,...
The ACCME sees content development for REMS as a three-stage process. The first two stages are under the control of the FDA and the final stage is under the control...
It is implicit in the FDA communications that the FDA expects that the opioid REMS CME will be commercially supported by the manufacturers and that the education developed by the...
The FDA has asked the manufacturers to submit their proposed REMS to the FDA for approval. Of direct relevance to ACCME-accredited providers is the FDA's instruction to manufacturers that the...
