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FDA guidance on prophylactic DNA vaccines: analysis and recommendations
Dennis M Klinman1, Sven Klaschik, Debra Tross
1Cancer and Inflammation Program, National Cancer Institute, Frederick, MD 21702, USA. klinmand@mail.nih.gov
Vaccine
|November 28, 2009
Abstract
None:
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.
