title: The "in-between" new drug application.
authors.forename: Gary D
authors.initials: GD
authors.lastname: Novack
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*