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# Metabolism Inborn Errors Guidance
- URL: https://www.fdaweb.com/metabolism-inborn-errors-guidance/
- Published: 2023-07-11T12:00:00.000Z
- Updated: 2026-09-14T18:43:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154848

FDA has published a draft guidance, *Inborn Errors of Metabolism that Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development*, with recommendations for optimizing and standardizing dietary management in clinical trials for developing drugs that treat inborn errors of metabolism for which dietary management is a key component of patients’ metabolic control. “Optimizing dietary management in these patients before entry into and during clinical trials is essential to providing an accurate evaluation of the efficacy of new drug products,” the [document](https://www.fda.gov/media/114764/download?ref=fdaweb.com) says.

The guidance does not discuss the general issues of statistical analysis or clinical trial design that are covered in other guidances.