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In 2017, the Asia-Pacific Economic Cooperation (APEC) forum designated USP as an APEC Center of Excellence (CoE) through the sponsorship of the U.S. Essential elements of a strong, global medicines supply chain The U.S. Pharmacopeia (USP) has long been recognized as an international leader in medicines quality and supply chain integrity.
Manufacturer-Focused Input Question 30: Off-Label Use. CMS has appropriately highlighted the significance of off- label use information, providing a specific avenue for manufacturers to submit data on off-label uses supported by evidence-based guidelines listed in CMS-recognized Part D compendia. and Keating, N. and Thom, B.
As CMS works to achieve this balance, the NHC would like to emphasize several limitations associated clinical guidelines : Off-Label Usage: Clinical guidelines typically do not cover off-label uses of medications, which can be significant for many patient populations, especially those with rare or complex conditions. and Keating, N.
3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. 11, December 2017, [link] www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Highlight- Vol11-Dec-2017.pdf. 29 Julia C.
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