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FDA guidance on prophylactic DNA vaccines: Analysis and recommendations

  1. Author:
    Klinman, D. M.
    Klaschik, S.
    Tross, D.
    Shirota, H.
    Steinhagen, F.

  2. Author Address

    [Klinman, Dennis M.; Tross, Debra; Shirota, Hidekazu; Steinhagen, Folkert] NCI, Canc & Inflammat Program, Frederick, MD 21702 USA. [Klaschik, Sven] Univ Hosp Bonn, Dept Anesthesiol & Intens Care Med, D-53105 Bonn, Germany.;Klinman, DM, NCI, Canc & Inflammat Program, Bldg 567 Rm 205, Frederick, MD 21702 USA.;klinmand@mail.nih.gov
    1. Year: 2010
    2. Date: Apr
  2. Journal: Vaccine
    1. 28
    2. 16
    3. Pages: 2801-2805
  4. Type of Article: Editorial Material
  5. ISSN: 0264-410X
  1. 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. Published by Elsevier Ltd.

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External Sources

  1. View Full Text
  2. DOI: 10.1016/j.vaccine.2009.11.025
  3. View record in Web of Science®
  4. WOS: 000276972100002

Library Notes

  1. Fiscal Year: FY2009-2010
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