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Participants in the FDA's Biomarker Qualification Program.

Mahnum Shahzad1,2, Ariel D Stern2,3

  • 1Department of Population Medicine, Harvard Pilgrim Health Care Institute, Harvard Medical School, Boston, Massachusetts, USA.

Clinical Pharmacology and Therapeutics
|April 9, 2025
PubMed
Summary

Academic organizations, not just pharmaceutical firms, are the primary applicants to the US Food and Drug Administration's Biomarker Qualification Program (BQP). This program validates biomarkers for drug development, with diverse stakeholders participating.

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