This guidance provides recommendations for establishing effectiveness for drugs intended to treat patients with 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.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required…