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GUIDANCE DOCUMENT

Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry August 2019

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry

Submit Comments by 10/14/2019

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-17463


Docket Number:
2019-17463
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs for treating idiopathic and diabetic gastroparesis. Specifically, this guidance addresses FDA’s current recommendations regarding clinical trial designs and clinical endpoint assessments to support developing gastroparesis drugs.

This draft guidance is intended to serve as a focus for continued discussions among the responsible FDA divisions in the Office of New Drugs, pharmaceutical sponsors, the academic community, and the public.