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the first stage would be a narrow but focused transitional step to promptly address the most pressing concern that hospitals in the lowest-performing quartile of the Safety of Care measure group achieve the highest possible Overall Hospital Quality Star Rating while allowing hospitals and interested parties more time to prepare for the second stage, which will increase the impact of the Safety of Care measure group across all hospitals more broadly

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Within a 68-page briefing document for the committee meeting, the FDAs own experts wrote that there is a lack of evidence to make a conclusion on the effectiveness of BPC-157 for treating ulcerative colitis and there already are FDA-approved drugs available to treat ulcerative colitis, and they proposed not adding BPC-157 to the 503A Bulks List