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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
This guidance provides sponsors who wish to submit an Investigational New Drug application (IND) for a therapeutic cancer vaccine with recommendations on critical clinical considerations for investigational studies of these products. This guidance will discuss considerations common to phase 1 and phase 2 clinical trials (collectively referred to as “early phase clinical trials”) and phase 3 clinical trials (referred to as “late phase clinical trials”), as well as considerations that are unique to specific stages of clinical development of therapeutic cancer vaccines. This guidance provides recommendations for the design of clinical trials for cancer vaccines conducted under an IND (Title 21 Code of Federal Regulations (21 CFR) Part 312) to support a subsequent biologics license application (BLA) for marketing approval. This guidance finalizes the draft guidance of the same title dated September 2009.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2009-D-0427.