September 11, 2018
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- Reviews: Qualification of Biomarker: clusterin (CLU), Cystatin-C (CysC), Kidney Injury Molecule-1 (KIM-1), N-acetyl-beta-D-
glucosaminidase (NAG), Neutrophil Gelatinase-Associated Lipocalin (NGAL), and osteopontin (OPN) - Biomarker Qualification Determination Letter (PDF - 83KB)
- Biomarker Qualification Program Office of Clinical Pharmacology Full Qualification Package Review (PDF - 509KB)
- Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated)
- Emerging Technology Program (updated)
- Clinical Review of PSTC/FNIH Kidney Safety Biomarker Qualification Submission (PDF - 1.4MB)
- Foundation for the National Institutes of Health Predictive Safety Testing Consortium Nephrotoxicity Working Group Executive Summary (PDF - 490KB)
- Statistical Review and Evaluation Biomarker Qualification (PDF - 2.9MB)
- Qualification Determination CPath Clinical Nephrotox Limited (PDF - 326KB)
- Review of CDRH Analytical validation consultation FNIH PSTC CM urinary biomarkers (PDF - 389KB)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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