Gastroparesis: Clinical Evaluation of Drugs for Treatment; Draft Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Gastroparesis: Clinical Evaluation of Drugs for Treatment." This draft guidance is intended to provide the FDA's current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis. This draft guidance replaces the draft guidance for industry of the same name issued July 23, 2015.