B. Biomarkers 811 Priority Line 826: are a number of questions regarding fully validated and the Please clarify: 819-826 regulations that are intended to apply to the laboratory activities, such as compliance with GLP, GCP CAP and CLIA. It is recommended that the new guidance clarify the expectations of the laboratory conditions and practices. 828-830
811 B. Biomarkers 819-826 Priority Please clarify: Line 826: are a number of questions regarding fully validated and the regulations that are intended to apply to the laboratory activities, such as compliance with GLP, GCP CAP and CLIA. It is recommended that the new guidance clarify the expectations of the laboratory conditions and practices. 828-830