Gastroparesis: Clinical Evaluation of Drugs for Treatment; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Gastroparesis: Clinical Evaluation of Drugs for Treatment." This draft guidance is intended to provide FDA's current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the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.