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GUIDANCE DOCUMENT

Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment Draft Guidance for Industry June 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2019-D-4656
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment.”  This draft guidance is intended to revise and replace the current draft guidance for industry entitled “Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment” issued on December 5, 2019.  This draft guidance provides recommendations for drug development programs for drugs intended to treat patients with interstitial cystitis/bladder pain syndrome (IC/BPS).

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All written comments should be identified with this document's docket number: FDA-2019-D-4656.

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