“Adaptive Licensing” Proposals View REMS As Answer To Limited Evidence

FDA’s Risk Evaluation and Mitigation Strategy program is being viewed as a potential tool to be used in “adaptive licensing” proposals, which suggest the risk management programs could expand from their current role of reducing serious drug risks to address products with limited evidence available at the time of initial approval.

Various ideas for new drug approval pathways, sometimes referred to as adaptive licensing or “progressive approval,” seem to look upon REMS (or the risk management plan concept) as a backstop...