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# CBER Untitled Letter on Cancer Immunotherapy
- URL: https://www.fdaweb.com/cber-untitled-letter-on-cancer-immunotherapy/
- Published: 2021-03-19T12:00:00.000Z
- Updated: 2026-09-14T16:51:36.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148925

CBER’s Office of Compliance and Biologics Quality has issued Reno Integrative Medical Center an untitled letter after reviewing the institution’s Web site ([*www.renointegrativemedicalcenter.com*](http://www.renointegrativemedicalcenter.com/?ref=fdaweb.com)) and determining its cancer immunotherapy product is a human cell, tissue, or cellular or tissue-based product requiring an approved BLA. The [letter](https://www.fda.gov/media/146675/download?ref=fdaweb.com) cited numerous claims the medical center is making to demonstrate that it is an unapproved biologic product. For example, one claim said: “Dendritic Cell Vaccine therapy offers a new promising immunotherapeutic approach for treatment of advanced cancer, as well as for secondary prevention of cancer.” FDA requested that Reno Integrative reply as to how it will comply with the agency’s applicable regulations.