Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines. It provides recommendations to sponsors who wish to submit an IND for a therapeutic cancer vaccine on critical clinical considerations for investigational studies of these products. It applies to therapeutic cancer vaccines that are intended to be administered to patients with an existing cancer for the purpose of treatment, but not to products intended to be preventive or to decrease the incidence of cancer. It does not apply to adoptive immunotherapeutic products such as T cell or NK cell products. To download this guidance, click here. To view this notice, click here.