title: Shifting the burden: restructuring the drug review process.
authors.affiliation: Otsuka Pharmaceutical Co., Ltd., Rockville, MD 20850.
authors.forename: B
authors.initials: B
authors.lastname: Scoville
mesh_terms: D002986:Clinical Trials as Topic; D004341:Drug Evaluation / Q000379:methods*; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D006801:Humans; D011785:Quality Assurance, Health Care; D014116:Toxicology; D014481:United States; D014486:United States Food and Drug Administration