FDA guidance on prophylactic DNA vaccines: analysis and recommendations

Vaccine. 2010 Apr 1;28(16):2801-5. doi: 10.1016/j.vaccine.2009.11.025. Epub 2009 Nov 24.

Abstract

The FDA has been regulating the conduct of prophylactic DNA vaccine trials in the US for nearly 15 years. This work describes the evolution of FDA policy over that period, the status of current regulatory guidance, and provides recommendations for further changes to facilitate development in this field.

Publication types

  • Historical Article
  • Review

MeSH terms

  • Clinical Trials as Topic
  • Drug Approval / history*
  • Drug Approval / methods*
  • Guidelines as Topic
  • History, 20th Century
  • History, 21st Century
  • Humans
  • United States
  • United States Food and Drug Administration
  • Vaccines, DNA / immunology*

Substances

  • Vaccines, DNA