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Theoharides TC, Stewart JM, Hatziagelaki E, Kolaitis G

Xie J, et al

While interest is understandable, clinical evidence, safety data, and regulatory approval matter

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Therefore, we are proposing to revise and renumber this regulation to deem an expansion exception request complete no later than 90 days after the end of the 60-day comment period if CMS does not receive written comments from the community, or no later than 90 days after the end of the 30-day rebuttal period, regardless of whether the requesting hospital submits a rebuttal statement, if CMS receives written comments from the community