2015-09-14 20:15:19 UTC

AGA Comments on FDA Draft Guidance on Gastroparesis Drugs

Sept. 15, 2015

AGA and FDA are committed to improving drug development for gastroparesis.

The AGA Center for Diagnostics and Therapeutics has submitted comments on FDA's recently released draft guidance document entitled “Gastroparesis: Clinical Evaluation of Drugs for Treatment.” The guidance provides insights on currently available methods to assess the severity of symptoms and efficacy of treatments.

This guidance document is an important step towards refining the process of developing crucial drugs for patients suffering from the effects of gastroparesis. AGA applauds FDA for starting this important discussion.

AGA’s comments center on the following areas:

  • Relationship between biomarkers (such as gastric emptying) and symptoms.
  • Currently available patient-reported outcome instruments.
  • Consideration of alternative trial designs.
  • The value, or lack thereof, of studying patients with idiopathic versus diabetic gastroparesis as separate populations.
  • Defining clinically meaningful changes and endpoints.

Review the FDA draft guidance and AGA's comments.

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