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# Guide on Pediatric Studies in Cancer Drugs
- URL: https://www.fdaweb.com/guide-on-pediatric-studies-in-cancer-drugs/
- Published: 2021-05-25T12:00:00.000Z
- Updated: 2026-09-14T17:00:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149397

*Federal Register* notice: FDA has made available a final guidance entitled *FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs*. The document addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs and biological products. FDA says the early pediatric evaluation of certain molecularly targeted oncology drugs as required by the FD&C Act is expected to accelerate the creation of an informed pediatric development plan and ultimately the development of promising drugs for pediatric patients. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-05-25/pdf/2021-11022.pdf?ref=fdaweb.com).