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# BIO Comments on Pediatric Cancer Drug Docket
- URL: https://www.fdaweb.com/bio-comments-on-pediatric-cancer-drug-docket/
- Published: 2022-04-28T12:00:00.000Z
- Updated: 2026-09-14T17:42:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151706

The Biotechnology Innovation Organization (BIO) says it agrees with FDA that the rarity of pediatric cancers may render investigations of multiple same-in-class products unfeasible. The comment is included in the trade association’s [response](https://downloads.regulations.gov/FDA-2021-N-1302-0003/attachment%5F1.pdf?ref=fdaweb.com) to the agency’s pediatric oncology subcommittee of the Oncologic Drugs Advisory Committee’s consideration of FDA’s planned development of a conceptual framework that will inform decision making on sponsor plans and requests for waivers of early pediatric investigations of molecularly targeted cancer drugs and biologics when multiple same-in-class products are approved and/or in development.

“In general,” the response says, “BIO believes the construction of a conceptual framework to assist FDA’s regulatory decision making should avoid unduly burdening one sponsor more than its competitors, utilize scientific data (e.g., mechanistic, nonclinical, clinical, etc.) and have a patient-centric approach.”