Igeneon Immunotherapy of Cancer, Vienna
Regulatory considerations for nonclinical cancer vaccine development are discussed
Published in Aging and Elder Health Week, June 18th, 2006
According to their report, "This paper discusses regulatory requirements essential during the non-clinical development of cancer vaccines. DNA vaccines and vaccines containing monoclonal antibodies are specifically addressed."
"ICH, CHMP, FDA, and WHO guidance documents in addition to scientific literature are reviewed and the regulatory framework, including respective EMEA and the FDA divisions responsible for review and assessment of cancer vaccines, is described," noted Monika...
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