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Guidance Documents Pharmaceutical Industry Prescription Drugs

Morgan Lewis

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

Morgan Lewis on

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

Smart & Biggar

Consultation open on Health Canada’s proposal on agile licensing for drugs and medical devices

Smart & Biggar on

UPDATE: The consultation period has been extended until April 26, 2023. On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under...more

American Conference Institute (ACI)

[Webinar] Special Guidance on DEA's COVID-19 Response Concerning the Production of Controlled Substance Medications - June 3rd,...

Complimentary webinar with the DEA on Controlled Substances! During this global pandemic, the Diversion Control Division is working to assure that there is an adequate supply of controlled substances in the United States,...more

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