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# Revised Guide Gastroparesis Drug Development
- URL: https://www.fdaweb.com/revised-guide-gastroparesis-drug-development/
- Published: 2019-08-13T12:00:00.000Z
- Updated: 2026-09-15T01:43:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144749

FDA has revised a 2015 draft guidance on “[Gastroparesis: Clinical Evaluation of Drugs for Treatment](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=FDA%20announces%20revision%20to%20Draft%20Guidance%20for%20Industry%20on%20developing%20drug&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=9182&elqTrackId=B7E01B4F27F2C1A6271A555A733320AA&elq=8b34fe38ce6c4011be9f02dc002da5b1&elqaid=9102&elqat=1).” The agency says new changes reflect its current thinking on developing clinical outcome assessment measures and statistical considerations for using those measures to assess primary and secondary efficacy endpoints of clinical trials for gastroparesis. The document discusses clinical trial designs, trial populations, approaches for outcome assessment measures, endpoints and statistical considerations. Comments are being accepted on the revisions over the next 60 days.