FDA announces opioid-related guidance, labeling changes

The Food and Drug Administration today issued draft guidance for companies developing generic versions of approved opioids with abuse-deterrent formulations. “For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option for patient care,” said FDA Commissioner Robert Califf, M.D. “We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse. But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy.” Also this week, FDA announced safety labeling changes for immediate release and other opioid prescription products.