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# Comments on FDA Draft RTOR Guidance
- URL: https://www.fdaweb.com/comments-on-fda-draft-rtor-guidance/
- Published: 2022-09-20T12:00:00.000Z
- Updated: 2026-09-14T17:59:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152777

The Alliance for Regenerative Medicine (ARM) says it appreciates the FDA targeted draft guidance on real-time oncology review (RTOR). The ARM comment [letter](https://www.regulations.gov/comment/FDA-2022-D-0823-0004?ref=fdaweb.com) makes suggestions in terms of eligibility and application of RTOR at CBER and for cell and gene therapy, alignment with the Oncology Center of Excellence RTOR Web site process description, and RTOR process clarification. The alliance also submitted specific line-by-line comments.

Pfizer [says](https://www.regulations.gov/comment/FDA-2022-D-0823-0005?ref=fdaweb.com) it particularly supports the expansion of RTOR from supplements to novel indications and is encouraged that FDA is directing sponsors to discuss the potential for using RTOR for cell and gene therapies with the appropriate review division. “The use of RTOR in these new and promising areas of drug development has the potential to streamline future reviews for the benefit of patients,” Pfizer says. The letter also includes specific line-by-line comments.