title: FDA perspective on regulatory issues in vaccine development.
authors.affiliation: Division of Bacterial Products, Food and Drug Administration, Bethesda, Maryland 20892, USA.
authors.forename: B F
authors.initials: BF
authors.lastname: Anthony
mesh_terms: D000907:Antibodies, Bacterial / Q000096:biosynthesis; D003140:Communicable Disease Control / Q000379:methods; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000592:standards; D004345:Drug Industry; D018073:Haemophilus Vaccines / Q000276:immunology; D006801:Humans; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*; D017778:Vaccines, Combined / Q000009:adverse effects / Q000592:standards*
chemical_list: D000907:Antibodies, Bacterial; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017778:Vaccines, Combined