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.
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US FDA officials say they need knowledge of the disease to have the confidence to use accelerated approval.
FDA tries to MaPP out how and when reviewers can be flexible, moving from 'one-off' to 'boutique' evaluation.
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.