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# Guide on Oncologic Drug Dose Optimization
- URL: https://www.fdaweb.com/guide-on-oncologic-drug-dose-optimization/
- Published: 2024-08-09T12:00:00.000Z
- Updated: 2026-09-14T14:37:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157540

*Federal Register* notice: FDA is making available a final guidance entitled “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.” The guidance is intended to assist sponsors in determining an optimized dosage for drugs/biologics used in treating oncologic diseases. The document does not address selecting a starting dose for first-in-human trials, nor dosage optimization for radiopharmaceuticals, cellular and gene therapy products, oncolytics, microbiota, or cancer vaccines. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-08-09/pdf/2024-17771.pdf?ref=fdaweb.com).