FDA guidance on prophylactic DNA vaccines: analysis and recommendations.
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.
Klinman
Dennis M
DM
Cancer and Inflammation Program, National Cancer Institute, Frederick, MD 21702, USA. klinmand@mail.nih.gov
Klaschik
Sven
S
Tross
Debra
D
Shirota
Hidekazu
H
Steinhagen
Folkert
F
D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000266:history* / Q000379:methods*; D017408:Guidelines as Topic; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration; D019444:Vaccines, DNA / Q000276:immunology*
D019444:Vaccines, DNA