title: FDA overview and current challenges in regulation of human subject protection. Food and Drug Administration.
authors.affiliation: Food and Drug Administration, Office of Health Affairs, Rockville, MD.
authors.forename: S L
authors.initials: SL
authors.lastname: Nightingale
mesh_terms: D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent; D017410:Practice Guidelines as Topic; D011367:Professional Staff Committees; D014481:United States; D014486:United States Food and Drug Administration