News & Analysis as of May 10, 2025

Regulatory Requirements

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Manufacturers Challenge CMS’s Definitions of ‘QSSD’ and ‘Bona Fide Marketing'

Morgan Lewis on 2/12/2025

Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price negotiation provisions. Recently filed suits contend that CMS has impermissibly expanded...more

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Constitutional Challenges › Guidance Documents › Regulatory Requirements

Manufacturers Challenge CMS’s Definitions of ‘QSSD’ and ‘Bona Fide Marketing'

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