title: FDA regulations and guidelines.
authors.affiliation: Center for Drug Evaluation and Research, FDA, Rockville, Maryland.
authors.forename: A
authors.initials: A
authors.lastname: Rothschild
mesh_terms: D004345:Drug Industry / Q000331:legislation & jurisprudence*; D007880:Legislation, Drug; D014481:United States; D014486:United States Food and Drug Administration