Cancer and Inflammation Program, National Cancer Institute, Frederick, MD 21702, USA.
Vaccine. 2010 Apr 1;28(16):2801-5. doi: 10.1016/j.vaccine.2009.11.025. Epub 2009 Nov 24.
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.
美国食品和药物管理局(FDA)已经对美国预防性 DNA 疫苗试验的实施进行了近 15 年的监管。这项工作描述了在此期间 FDA 政策的演变、当前监管指南的现状,并提出了进一步改革的建议,以促进该领域的发展。