2023-11899: Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment; Revised Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment." This draft guidance is intended to revise and replace the current draft guidance for industry entitled "Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment" issued on December 5, 2019. This draft guidance provides recommendations for drug development programs for drugs intended to treat patients with interstitial cystitis/bladder pain syndrome (IC/BPS).
The agency’s own summary, as published.
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