Regulatory approach toward vaccines against cancer: the benefit/risk ratio.

Decisions regarding investigational new drug applications for testing of all biologicals to be used in humans, including those designed to prevent or treat cancers, must be considered in terms of benefit/risk ratios. In order for a regulatory organization to make the appropriate decision regarding the testing of new biologicals in humans, it must have an extremely broad dialog within the critical scientific public and the general public, which are represented on committees functioning in the Bureau of Biologics. There must be a generaly consensus regarding the benefit/risk ratio of proposed new biologicals for scientific progress and the effective regulation of biologicals.