Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment

On 4 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 2 February 2020.

This draft guidance provides FDA's recommendations for clinical trials intended to establish clinical effectiveness and safety for drugs intended to treat Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).

This guidance incorporates recommendations the FDA received at a December 2017 advisory committee meeting on trial design features, including enrollment criteria and acceptable effectiveness endpoints for drugs intended to treat IC/BPS.

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