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