Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment: Draft Guidance for Industry

Issue Date: June 2, 2023
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Draft

Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment: Draft Guidance for Industry

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment.” This draft guidance is intended to revise and replace the current draft guidance for industry entitled “Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment” issued on December 5, 2019. This draft guidance provides recommendations for drug development programs for drugs intended to treat patients with interstitial cystitis/bladder pain syndrome (IC/BPS).

Download the Guidance Document