Opioid Prescriber Knowledge Assessment Due Year After Patient Assessment
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.
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While Belbuca represents a new formulation, it does not contain the abuse-deterrent properties that FDA has been encouraging.
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.
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.