The Committee discussed appropriate patient selection criteria and clinical trial design features, including acceptable endpoints, for demonstrating clinical benefit for drugs intended to treat interstitial cystitis and bladder pain syndrome. The Committee also discussed whether bladder pain syndrome and interstitial cystitis reflect overlapping or different populations, and whether it is appropriate to assess efficacy in the same way for both conditions.
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Earlier Event: November 30
Blood Products Advisory Committee
Later Event: January 9
Bone, Reproductive and Urologic Drugs Advisory Committee