Record-Setting REMS: FDA’s Classwide Opioid Program Will Be “Massive”
FDA is starting the process of developing a classwide Risk Evaluation & Mitigation Strategy for potent opioid drug products - with the resulting program expected to be the most extensive REMS required by the agency since the implementation of the FDA Amendments Act
You may also be interested in...
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.
By the third year of continuing medical education efforts, FDA expects 60% of those who wrote a prescription for a long-acting/extended-release opioid in 2011 to receive training.
ProStrakan's Abstral is first use of the REMS templates; the agency expects sponsors of similar immediate-release transmucosal products to follow suit and share a REMS implementation system.