title: US FDA review and regulation of preventive vaccines for infectious disease indications: impact of the FDA Amendments Act 2007.
abstract: Vaccines for prevention or treatment of infectious diseases are biological products that are regulated by the Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research of the US FDA. The legal framework for the regulation of vaccines derives primarily from Section 351 of the Public Health Service Act and from certain sections of the Federal Food, Drug and Cosmetic Act (FFD & C Act). The FDA Amendments Act of 2007 (FDAAA 2007) includes extensive modifications to the FFD & C Act. This article provides an overview of the review process for preventive vaccines and highlights applicable statutory provisions. In addition, this article will discuss changes in the pre-and post-licensure evaluation process for preventive and therapeutic infectious disease vaccines since implementation of the FDAAA 2007.
authors.affiliation: Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, DHHS, 1451 Rockville Pike, WOCII Room 3312, Rockville, MD 20852, USA. marion.gruber@fda.hhs.gov
authors.forename: Marion F
authors.initials: MF
authors.lastname: Gruber
mesh_terms: D003141:Communicable Diseases / Q000628:therapy*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D007878:Legislation as Topic; D060735:Pharmacovigilance; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*; D014612:Vaccines / Q000627:therapeutic use*
chemical_list: D014612:Vaccines