title: A defined-risks approach to the regulatory assessment of the use of neoplastic cells as substrates for viral vaccine manufacture.
authors.affiliation: Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food And Drug Administration, Bethesda, MD 20892, USA.
authors.forename: A M
authors.initials: AM
authors.lastname: Lewis
authors.forename: P
authors.initials: P
authors.lastname: Krause
authors.forename: K
authors.initials: K
authors.lastname: Peden
mesh_terms: D004345:Drug Industry / Q000331:legislation & jurisprudence*; D006801:Humans; D012306:Risk; D014407:Tumor Cells, Cultured; D014765:Viral Vaccines
chemical_list: D014765:Viral Vaccines