FDAnews Drug Daily Bulletin
July 17, 2012 | Vol. 9 No. 139
FDA Rolls Out Long-Awaited Opioid REMS
Manufacturers of extended-release and long-acting (ER/LA) opioid pain relievers will need to have educational programs available for prescribers by March of next year, according to a new classwide risk evaluation and mitigation strategy (REMS) that has been in the works for years. The REMS will affect 20 companies and more than 30 products, including both brand and generic drugs. The manufacturers, including OxyContin (oxycodone hydrochloride) maker Purdue Pharma and Avinza (morphine sulfate) producer Pfizer, will fund the training through educational grants to continuing education providers, which will be responsible for training development and delivery, the FDA said.
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