To account for these variations, a full calendar year was selected as the measure's performance period, to allow time to capture seasonal variations in the reported outcomes and allow hospitals and health systems sufficient time to analyze data and implement quality improvement efforts
The STAT News coverage noted that if the FDA ultimately reclassifies the compounds and they are produced by compounding pharmacies, clinicians would have discretion to prescribe them outside the narrow indications under review, meaning a substance reviewed only for ulcerative colitis could legally be prescribed for any purpose a physician deemed appropriate
Elinav E, Nowarski R, Thaiss CA, Hu B, Jin C, Flavell RA
Human clinical evidence remains limited, and individual results cannot be guaranteed
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