# Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/inborn-errors-of-metabolism-that-use-dietary-management-considerations-for-optimizing-and-standardizing-diet-in-clinical-trials-for-drug-product-development-draft-guidance-for-industry/325cca3e-8b3a-4f04-9dda-5271c7389dd4

> FDA guidance document: Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Draft Guidance for Industry. Issue date: July 12, 2023. Get complete insights and analysis.

---

## Details

- Title: Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Draft Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2023-07-12
- Comment Close Date: 2023-09-11
- Last Changed: 2024-04-11
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-2647">FDA-2018-D-2647</a>

## Related Documents

- [Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act:  Scientific Considerations](https://www.globalkeysolutions.net/guidances/guidance-document/pediatric-drug-development-under-the-pediatric-research-equity-act-and-the-best-pharmaceuticals-for-children-act-scientific-considerations/ec636095-c1f7-4772-8dae-ff1ea7ee80fc)
- [Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; Availability](https://www.globalkeysolutions.net/guidances/guidance-document/measuring-growth-and-evaluating-pubertal-development-in-pediatric-clinical-trials-draft-guidance-for-industry-availability/b3766e09-0a47-4099-a69c-f48ac2979eb8)
- [Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials](https://www.globalkeysolutions.net/guidances/guidance-document/pregnant-women-scientific-and-ethical-considerations-for-inclusion-in-clinical-trials/674ff9d8-e752-4113-b7fd-bc85b7646bd3)