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.
You may also be interested in...
FDA Flexible With Accelerated Approval Evidence, Analysis Finds
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.
Biomarkers In Orphan Studies Still Need Past Experience, FDA Says
Rare Disease groups work to finalize white paper on accelerated approval, but FDA questions whether a rules-based biomarker qualification process is possible.
Paging Dr. McClellan: FDA Calls On Brookings For PDUFA Research
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.