title: Biomarker qualification pilot process at the US Food and Drug Administration.
abstract: New biomarkers of safety and efficacy are becoming powerful tools in drug development. Their application can be accelerated if a consensus can be reached about their qualification for regulatory applications. This consensus requires a review structure within the US Food and Drug Administration (FDA) that can evaluate qualification data for these biomarkers and determine whether these biomarkers can be qualified. A pilot process and corresponding Biomarker Qualification Review Team have been developed to test how the FDA can work on biomarker qualification.
authors.affiliation: Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20903-0002, USA. Federico.goodsaid@fda.hhs.gov
authors.forename: Federico
authors.initials: F
authors.lastname: Goodsaid
authors.forename: Felix
authors.initials: F
authors.lastname: Frueh
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D004364:Pharmaceutical Preparations / Q000592:standards; D010865:Pilot Projects; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers; D004364:Pharmaceutical Preparations