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Essential elements of a strong, global medicines supply chain

Quality Matters

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.

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NHC Comments on Negotiation Data Elements and Drug Price Negotiation Process for Initial Price Applicability Year 2027 under Sections 11001 and 11002 of the IRA ICR Forms

Putting Patients First Blog

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.

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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027

Putting Patients First Blog

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.

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NHC Submits Comments to CMS RE CY 2026 Policy & Technical Changes to MA and Part D Proposed Rule

Putting Patients First Blog

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.