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The FDA has also issued communications regarding unapproved GLP-1 drugs, emphasizing that products containing investigational compounds have not undergone the same review for safety, effectiveness, and quality as approved medications [2]

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and (2) clarify that if a third party intermediary does not submit data for one year, they would be required to provide documentation and would be terminated if documentation cannot be provided and/or the documentation shows that they would not be submitting data for the given MIPS performance period