title: FDA regulatory reform.
authors.affiliation: Biopharmaceutical Consulting Services, BRI International Inc., Arlington, VA 22209-3801, USA.
authors.forename: M
authors.initials: M
authors.lastname: Beatrice
mesh_terms: D001688:Biological Products / Q000592:standards*; D001702:Biopharmaceutics / Q000331:legislation & jurisprudence*; D001709:Biotechnology / Q000331:legislation & jurisprudence*; D004274:DNA, Recombinant; D007885:Legislation, Pharmacy; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products; D004274:DNA, Recombinant