Interstitial Cystitis/Bladder Pain Syndrome: Establishing Effectiveness of Drugs for Treatment; Draft Guidance for Industry; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment." There is pharmaceutical and stakeholder interest in the development of new drugs for patients with IC/BPS. This draft guidance provides FDA's recommendations for clinical trials intended to establish clinical effectiveness and safety for drugs intended to treat IC/BPS.