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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.” This draft guidance describes FDA’s current recommendations for optimizing and standardizing dietary management in clinical trials for the development of drug products intended to treat inborn errors of metabolism (IEM) when dietary management is a key component of patients’ metabolic control. Optimizing and standardizing dietary management in these patients before they enter clinical trials and during clinical trials is essential to providing an accurate evaluation of the efficacy of new drug products. This guidance revises the draft guidance of the same name issued on July 24, 2018.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-2647.