2023, HIPAA and Labelling - Pharmacist Digest

NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair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

JULY 2, 2024

The discussion focused on CMS’ 2023 listening sessions during implementation of the first round of negotiations and identified lessons learned to inform future listening sessions and broader patient engagement strategies. It is crucial to consider how off-label uses will be evaluated and incorporated into the negotiation process.

Drug Pricing

Drug Pricing Insurance Coverage and Processing Labelling HIPAA

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law Blog: Biosimilars

MAY 26, 2025

Were not trying to bury the lead here, but the battle of labeling these surgical and drug treatments is a political one. And the memo goes one step more arguing that, even if otherwise truthful, promotion of off-label uses of hormones can run afoul of FDA prohibitions on misbranding and mislabeling. See United States v. Facteau , 89 F.4th

Labelling

Labelling HIPAA Documentation Pharmaceutical Companies

NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair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

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

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