title: Presumption of innocence: FDA's authority to regulate the specifics of prescription drug labeling and the preemption debate.
authors.affiliation: Bayer HealthCare LLC, West Haven, CT, USA.
authors.forename: Howard L
authors.initials: HL
authors.lastname: Dorfman
authors.forename: Vivian M
authors.initials: VM
authors.lastname: Quinn
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Brophy
mesh_terms: D004345:Drug Industry / Q000266:history / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D011307:Drug Prescriptions; D017007:Duty to Warn / Q000331:legislation & jurisprudence; D035082:Federal Government; D033161:Government Regulation; D049673:History, 20th Century; D006801:Humans; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations; D013219:State Government; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations