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# PhRMA’s 4 Open FDARA Implementation Issues
- URL: https://www.fdaweb.com/phrmas-4-open-fdara-implementation-issues/
- Published: 2024-05-23T12:00:00.000Z
- Updated: 2026-09-14T14:31:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157053

Pharmaceutical Research and Manufacturers of America (PhRMA) says there are four key, open FDA Reauthorization Act (FDARA) implementation issues that FDA should address. In its comment [letter](https://downloads.regulations.gov/FDA-2024-N-1157-0005/attachment%5F1.pdf?ref=fdaweb.com) submitted to the docket for the Pediatric Oncology Subcommittee 5/22 meeting to discuss perspectives relating to implementation of FDARA, PhRMA identifies the issues as:

- clarifying the evidentiary standard that it applies to determine if a molecular target is “substantially relevant” to the growth or progression of a pediatric cancer;
- confirming that an applicant may submit, but is not obligated to generate, nonclinical data to inform a substantial relevance determination;
- establishing a time-bound process for deciding whether the molecularly targeted pediatric cancer investigation requirement applies to an application; and
- confirming the inapplicability of the traditional Pediatric Research Equity Act assessment requirement to an orphan-designated indication for which the molecularly targeted pediatric investigation requirement does not apply.