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# Guide on Metabolism Inborn Errors
- URL: https://www.fdaweb.com/guide-on-metabolism-inborn-errors/
- Published: 2023-07-12T12:00:00.000Z
- Updated: 2026-09-14T18:43:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154862

*Federal Register* notice: FDA is making available a revised draft guidance entitled “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.” The document describes FDA’s current recommendations for dietary management in clinical trials for drugs intended to treat inborn metabolism errors when dietary management is a key component of patients’ metabolic control. The guidance says optimizing dietary management in these patients is important to providing an accurate efficacy evaluation of new drug products. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-07-12/pdf/2023-14691.pdf?ref=fdaweb.com).