6/4/2013

Providers who conduct fecal transplants must submit investigational new drug applications, according to the FDA, and physicians say the requirement could bring the procedures to a halt. The method is used to introduce a new population of bacteria in the treatment of patients with gastrointestinal symptoms, particularly those caused by Clostridium difficile. The FDA is seeking to "provide regulatory clarity" and to ensure valid trials, agency spokesman Curtis Allen said.

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