Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2007-2012
Drug Sponsor Medical Review Clinical Pharmacology Review Statistical Review BPCA or PREA or Both Abacavir - Ziagen GlaxoSmithKline Medical (PDF - 588KB) Clinical pharmacology (PDF - 248KB) None PREA Abatacept - Orencia Bristol-Myer-Squibb Medical (PDF -8MB …