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.
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Decision to replace the rosiglitazone REMS’ distribution restrictions with prescriber training reflected a consensus opinion shared by leadership in three CDER offices, despite a poll of reviewers who participated in a June advisory committee meeting and favored eliminating the risk management program.
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