Biomarker Development Meeting May Help Expand Accelerated Approval
This article was originally published in Pharmaceutical Approvals Monthly
FDA could develop more guidance on how sponsors can qualify potential surrogate endpoints.
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Attorneys Sasinowski and Varond write that in some cases weak clinical evidence on the surrogate endpoint was not a barrier, but strong findings on unmet need and rarity usually are necessary for accelerated approval.
Rare Disease groups work to finalize white paper on accelerated approval, but FDA questions whether a rules-based biomarker qualification process is possible.
Brookings’ Engelberg Center for Health Care Reform invited to help FDA research REMS and risk-benefit standardization, patient-reported outcomes, and other issues that were mandated in PDUFA V.