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# FDA Exempts Evoke Pharma from Human Factors Study
- URL: https://www.fdaweb.com/fda-exempts-evoke-pharma-from-human-factors-study/
- Published: 2017-02-15T12:00:00.000Z
- Updated: 2026-09-14T22:06:40.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5137990

FDA has exempted Evoke Pharma from having to perform a human factors validation study requirement prior to submitting an NDA on its late stage product Gimoti (metoclopramide nasal spray) for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Last year, FDA released a [draft guidance](http://www.fda.gov/RegulatoryInformation/Guidances/UCM484345?ref=fdaweb.com) on *Human* *Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development that outlined* the underlying principles of human factors studies during the development of combination products.

Evoke says it recently evaluated the need for human factors study and submitted an assessment report to FDA for Gimoti using a “Failure Mode and Effects Analysis risk analysis taking into account the intended uses, users, use environments, product-user interface, and associated medical factors.” FDA responded that it had adequately considered the risks associated with the proposed nasal spray and determined that a validation study is not needed at this time, the company says. An NDA submission is being planned by the year end.

  
Diabetic gastroparesis is a gastrointestinal disorder in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the U.S. to treat gastroparesis, and is currently available only in oral and intravenous forms.