Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Drugs for Treatment; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment." This guidance is intended to assist the pharmaceutical industry and investigators who are developing drugs for the treatment of irritable bowel syndrome (IBS), specifically the IBS indications for IBS with diarrhea (IBS-D) and IBS with constipation (IBS-C). The guidance describes the evolution of patient-reported outcome (PRO) measures as primary endpoints for IBS clinical trials, and sets forth provisional endpoints and trial design recommendations that sponsors may apply to IBS clinical trials as PRO measurements continue to evolve. The guidance also discusses the future development of IBS PRO instruments. This guidance finalizes the draft guidance published in March 2010.