Will US FDA Remove Higher Strength Opioids From The Market?
Advisory committee members are divided on whether agency should restrict access to higher dose opioids, but most want option kept on the table.
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Labeling should include signs and symptoms of withdrawal as well as abuse-deterrent properties, draft guidance states.
Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety data.
Beyond considering removal from the market, US FDA advisory panel suggests actions agency could take to improve the safety of higher dosage strength opioids.