Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
Drug Sponsor Sponsor Medical Review Clinical Pharmacology Review Statistical Review BPCA or PREA or Both Abametapir - Xeglyze HATCHTECH PTY LTD Medical (PDF - 4 MB) Addendum (PDF - 78 KB) CDTL (PDF - 3 MB) Resubmission (PDF - 77 KB) DD (PDF - 2 MB) …