Biomarker Development Meeting May Help Expand Accelerated Approval
This article was originally published in The Pink Sheet Daily
FDA could develop more guidance on how sponsors can qualify potential surrogate endpoints.
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CDER Director Woodcock says agency should write down its definition of a surrogate endpoint, but industry and academics will have to help with requirements for biomarker approval.
FDA wants data standards in place so the increasingly popular clinical research collaborations can continue growing, but a researcher states that government also could make funding available to sustain the consortia.
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.