Opioid Prescriber Knowledge Assessment Due Year After Patient Assessment
Executive Summary
REMS assessment schedule for the long-acting/extended release opioid products reflects the large number of drugs, prescribers and patients involved in the risk management program and the time needed to put all its components in place.
You may also be interested in...
Endo's Belbuca Is First Buccal Film In Extended-Release Opioid Class
While Belbuca represents a new formulation, it does not contain the abuse-deterrent properties that FDA has been encouraging.
Opioid Post-marketing Studies: Can Sponsors Work Well Together Again?
FDA wants to get a handle on how long-term use of long-acting pain killers relates to abuse and misuse; the agency also is requiring labeling changes that remove “moderate” pain from the products’ indication.
Shared REMS Systems Show Challenges Of Standardization – Could PDUFA V Help?
Hurdles to developing multi-sponsor programs include disagreements on design, decision-making and cost-sharing. PDUFA V initiatives on standardizing and integrating REMS could give FDA a means for providing more formal guidance or rulemaking on developing shared systems, as some in industry have requested.