title: Changes in regulations for approval  of therapeutics.
authors.forename: Janice M
authors.initials: JM
authors.lastname: Reichert
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007167:Immunotherapy / Q000379:methods* / Q000639:trends; D018570:Risk Assessment; D012926:Social Control, Formal; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000911:Antibodies, Monoclonal