title: FDA regulatory requirements for investigational new drugs and new drug applications: an update.
authors.affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20857.
authors.forename: C P
authors.initials: CP
authors.lastname: Hoiberg
authors.forename: R S
authors.initials: RS
authors.lastname: Rapaka
mesh_terms: D002170:Canada; D015507:Drugs, Investigational / Q000627:therapeutic use*; D006801:Humans; D007880:Legislation, Drug; D009965:Orphan Drug Production; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015507:Drugs, Investigational