title: Critically reviewing impact of regulatory actions, not just FDA's.
authors.affiliation: Department of Clinical Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands; Dutch Medicines Evaluation Board, Utrecht, The Netherlands.
authors.forename: Peter G M
authors.initials: PG
authors.lastname: Mol
mesh_terms: D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D023381:Endpoint Determination / Q000379:methods*; D033161:Government Regulation; D012107:Research Design