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# Oncologic Drug Dosage Guidance
- URL: https://www.fdaweb.com/oncologic-drug-dosage-guidance/
- Published: 2024-08-08T12:00:00.000Z
- Updated: 2026-09-14T14:37:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157531

FDA has published a guidance, *Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases*, to help sponsors identify an optimized dosage during clinical development and before applying for approval of a new indication and usage. The agency says the [document](https://www.fda.gov/media/164555/download?ref=fdaweb.com) should be considered along with the 11/1994 International Conference on Harmonization E4 guidance on *Dose-Response Information to Support Drug Registration* when identifying an optimized dosage.

The guidance does not specifically provide recommendations addressing dosage optimization for radiopharmaceuticals, cellular and gene therapy products, oncolytic viruses, microbia, or cancer vaccines, FDA says. However, it adds, some of the recommendations may apply to those therapeutic modalities. The guidance also does not address pediatric drug development, for which, FDA says, there are unique considerations. Finally, the guidance does not address selection of the starting dose for first-in-human trials.