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FDA's Advisory Cmte. Meeting On Bladder Pain Syndrome May Signal Policy Changes

 
• By Derrick Gingery

The Bone, Reproductive and Urologic Drugs Advisory Committee will consider endpoints, clinical trial designs and other issues related to development in the disease.

FDA entrance sign 2016
The advisory committee meeting could lead to policy changes in painful bladder syndrome.

FDA may be on the verge of changing the endpoints and other trial design policies for drugs targeting interstitial cystitis and bladder pain syndrome.

The agency's Bone, Reproductive and Urologic Drugs Advisory Committee will discuss patient selection criteria and clinical trial design features, including "acceptable endpoints," to show benefit for drugs in both conditions.

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