title: Current status and future trends in vaccine regulation--USA.
abstract: In regulating vaccines, the US Food and Drug Administration (FDA) is governed by the Code of Federal Regulations. These regulations serve as the framework for product characterization, as well as preclinical and clinical testing strategies. Novel vaccine approaches such as combination vaccines, vectored vaccines, new adjuvants, and novel delivery systems pose unique regulatory challenges for the FDA. If US licensure is sought, communication with the FDA throughout the clinical development of a product is essential to identify and implement the appropriate strategies for demonstrating the safety and effectiveness of a new product.
authors.affiliation: Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, FDA HFM #481, 1401 Rockville Pike, Rockville, MD 20852, USA. falk@cber.fda.gov
authors.forename: L A
authors.initials: LA
authors.lastname: Falk
authors.forename: L K
authors.initials: LK
authors.lastname: Ball
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000009:adverse effects / Q000592:standards; D016503:Drug Delivery Systems / Q000009:adverse effects / Q000592:standards; D004353:Drug Evaluation, Preclinical / Q000009:adverse effects / Q000592:standards; D004345:Drug Industry / Q000592:standards*; D005822:Genetic Vectors / Q000009:adverse effects / Q000235:genetics / Q000592:standards; D008004:Licensure; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence* / Q000639:trends*; D014612:Vaccines / Q000009:adverse effects / Q000592:standards* / Q000627:therapeutic use; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use; D017778:Vaccines, Combined / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use
chemical_list: D000276:Adjuvants, Immunologic; D014612:Vaccines; D014613:Vaccines, Attenuated; D017778:Vaccines, Combined