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Comment: The applicant acknowledged that CMS applies a high evidentiary standard for substantial clinical improvement, typically requiring robust clinical data showing improved patient outcomes such as reduced complications, fewer reoperations, faster recovery, or better functional results compared to the current standard of care

When a compound has no completed human trial, there is by definition no safety data in any subgroup no pregnancy data, no hepatic-impairment data, no interaction data with common metabolic or endocrine medications

10 FDA Drug Safety CommunicationIV/injectable glutathione for skin whitening is not approved by any route in the United States