title: How FDA approves biotechnology drugs.
authors.affiliation: University of Kentucky College of Pharmacy, Lexington, USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Manuel
authors.forename: P
authors.initials: P
authors.lastname: Piascik
mesh_terms: D001709:Biotechnology / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000379:methods; D004345:Drug Industry / Q000331:legislation & jurisprudence; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration