FDA - Focus On Opioid Manufacturer REMS FDAAA

Updated September 15, 2016

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Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids (FDA.gov)

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If you're involved in or follow opioid manufacturing, you'll want to follow the FDA's focus on manufacturers of certain opioid drug products. FDA indicates that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks. The affected opioid drugs include brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) when necessary to ensure that the benefits of a drug outweigh the risks. You can expect to hear more about this over the next several months from the FDA.

More FDA Information About This Topic:
Transcript for FDA's Media Briefing on the Safe Use of Opioids
February 9, 2009 [pdf 52 KF] Audio [5.09 MB MP3]
FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs

Previous Posts:
Opiates Can Kill Kids!

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FDA Creates New Web Page of Drug Safety Information

Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs, "Postmarket Drug Safety Information for Patients and Providers." On this page you'll find many resources organized in the following categories . .

• Drug Labeling
• Risk Evaluation and Mitigation Strategies (REMS)
• Studies and Clinical Trials of Approved Products Required by FDA or Agreed to by the Application Holder
• Registries and Clinical Trials
• Memorandum of Agreement Between the Office of New Drugs and the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research
• Latest Safety Information
• Reporting Problems to the FDA
• Warnings and Recalls
• Regulations and Guidance Documents
• Information about FDA's Drug Safety Oversight Board (DSB)
• Using Medicines Safely
• Consumer Articles on Drug Safety
• General Health Information
• FDA's Response to the Institute of Medicine's 2006 Report

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