Biomarker Guidance To Encompass More Than Biomarkers, FDA Says
The draft guidance for biomarker qualification FDA is developing has taken a turn mid-stream and will focus on an array of drug development tools
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Biomarker Approvals At Pre-IND Stage Requested For Orphan Drugs
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Biomarkers, PRO Tools Warrant Separate Qualification Guidelines, Groups Tell FDA
FDA’s midstream decision to expand a biomarker qualification draft guidance to include patient-reported outcome tools has perplexed pharma stakeholders, which seem to think the agency would have been better off leaving well enough, and PROs, alone.