ARTICLE | Product R&D
Biomarkers’ road less traveled
Why FDA’s biomarker guidance means consortia will still be in the driver’s seat
January 11, 2019 4:29 AM UTC
FDA’s draft guidance on biomarker qualification provides welcome codification of the regulatory path. But the amount of data required may remain beyond the reach of most companies, strengthening the importance of consortia.
The guidance, issued Dec. 10, outlines the process for obtaining approval of a biomarker for a specific preclinical or clinical purpose, and applies to biomarkers intended for making decisions about safety or efficacy. ...
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