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# Changes Suggested for Cancer Drug Dosing Guidance
- URL: https://www.fdaweb.com/changes-suggested-for-cancer-drug-dosing-guidance/
- Published: 2023-03-21T12:00:00.000Z
- Updated: 2026-09-14T18:21:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154026

The Friends of Cancer Research says an FDA draft guidance on optimizing the dosage of human prescription drugs and biologic products to treat oncologic diseases “provides an essential framework to ensure patients receive drugs and biological products … at a dosage that is not only most efficacious and safe, but also the most tolerable.” The organization’s [comment letter](https://downloads.regulations.gov/FDA-2022-D-2827-0010/attachment%5F1.pdf?ref=fdaweb.com) says that while FDA recommends in the guidance key analyses to identify the optimal dosage, there are aspects where additional information and clarification regarding clinical trial design and data analysis would support the optimal implementation of the guidance:

- proposals for trial implementation;
- practical considerations for multiple doses;
- approach to data interpretation;
- additional considerations for expedited programs; and
- opportunities for early and frequent communications between sponsors and FDA.