title: Legal issues and impact of restricted access and distribution.
authors.affiliation: Patton Boggs, Washington, DC, USA.
authors.forename: D A
authors.initials: DA
authors.lastname: Kracov
mesh_terms: D006801:Humans; D007880:Legislation, Drug; D012308:Risk Management / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*