title: Proteomics quality and standard: from a regulatory perspective.
abstract: Proteomics has emerged as a rapidly expanding field dealing with large-scale protein analyses. It is anticipated that proteomics data will be increasingly submitted to the U.S. Food and Drug Administration (FDA) for biomarker qualification or in conjunction with applications for the approval of drugs, medical devices, and other FDA-regulated consumer products. To date, however, no established guideline has been available regarding the generation, submission and assessment of the quality of proteomics data that will be reviewed by regulatory agencies for decision making. Therefore, this commentary is aimed at provoking some thoughts and debates towards developing a framework which can guide future proteomics data submission. The ultimate goal is to establish quality control standards for proteomics data generation and evaluation, and to prepare government agencies such as the FDA to meet future obligations utilizing proteomics data to support regulatory decision.
authors: Division of Systems Biology, National Center for Toxicological Research, Food and Drug Administration, USA.
authors: Qiang
authors: Q
authors: Gu
authors: Division of Systems Biology, National Center for Toxicological Research, Food and Drug Administration, USA. Electronic address: Lirong.Yu@fda.hhs.gov.
authors: Li-Rong
authors: LR
authors: Yu
mesh_terms: D017408:Guidelines as Topic; D040901:Proteomics / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards* / Q000639:trends; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration
keywords: Biomarker qualification; Mass spectrometry; Proteomics; Quality control; Regulatory decision; Standards