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# Stakeholders’ Pediatric Oncology Comments
- URL: https://www.fdaweb.com/stakeholders-pediatric-oncology-comments/
- Published: 2018-06-21T12:00:00.000Z
- Updated: 2026-09-15T00:15:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141743

Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the goals of the 2017 Food and Drug Reauthorization Act to advance research and development of medicines for children with cancer. The association’s [letter](https://www.regulations.gov/document?D=FDA-2018-N-1577-0004&ref=fdaweb.com) submitted in advance of the 6/20 meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee urges FDA to “address key procedural and substantive issues related to implementation well in advance of the effective date in order to provide sponsors with predictability as they make important drug development decisions for oncology medicines.” PhRMA recommends that FDA: 

- develop clear, time-bound procedures for determining whether an oncologic medicine is subject to the new investigation requirement or to the requirement for claim-based assessments under section 505B(a)(1)(A) and 505B(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act; and
- solicit input on the meaning of “substantially relevant” and the evidence necessary to establish that a target is substantially relevant to the growth or progression of pediatric cancer.

It also notes that the meeting notice did not mention the statutorily-required list of targets for which the new investigation requirement is automatically waived, and describes the “statutorily relevant” target list differently than the statute does.

The Biotechnology Innovation Organization (BIO) [comments](https://www.regulations.gov/document?D=FDA-2018-N-1577-0006&ref=fdaweb.com) that it strongly supports prioritization of molecular targets based on public health concerns, to address major unmet medical needs, such as more frequently occurring pediatric cancers that lack suitable treatments. “To ensure productive discussion on the topic,” BIO says, FDA should “clarify what FDA means by the term ‘prioritization.’ As noted, BIO believes that the concept of prioritization should include consideration of prioritization by cancer, molecular target, and drug or biologic.”