FDA Announces Safety Labeling Changes, Postmarket Study Requirements for Opioids

September 20, 2013 | Strategic Insights for Ambulatory Care


The U.S. Food and Drug Administration (FDA) has announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting opioid analgesics intended to treat pain. According to a September 10, 2013, FDA press release, the new requirements demonstrate the agency’s resolve to reduce the serious risks of long-acting and extended-release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain.

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