FDA regulatory requirements for investigational new drugs and new drug applications: an update.
Hoiberg
C P
CP
Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20857.
Rapaka
R S
RS
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
D015507:Drugs, Investigational