federal_register: 2016-06889

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2016-06889 Seventh Annual Predictive Safety Testing Consortium/Food and Drug Administration Scientific Workshop; Public Workshop Notice The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER), in cosponsorship with the Critical Path Institute (C-Path), is announcing a public scientific workshop to discuss the impact of safety biomarkers on drug development. The purpose of the workshop is to discuss the following issues: Application of toxicometrics as a translational safety strategy that integrates nonclinical and clinical safety approaches; uses of rodent and non- rodent nonclinical species in biomarker qualification; and assay validation aspects during biomarker development and qualification. 2016-03-28 2016 3 https://www.federalregister.gov/documents/2016/03/28/2016-06889/seventh-annual-predictive-safety-testing-consortiumfood-and-drug-administration-scientific-workshop https://www.govinfo.gov/content/pkg/FR-2016-03-28/pdf/2016-06889.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER), in cosponsorship with the Critical Path Institute (C-Path), is announcing a public scientific workshop to discuss the impact of safety biomarkers on drug...  

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