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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair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

Enhance Dialogue-Based Engagement Clarify Required Disclosures Allow HIPAA Waivers if Feasible Clarify Speaker Selection Process Allow for Data Submissions After Sessions Increase Engagement. Without appropriate guardrails, CMS’ broad definition of drugs eligible for negotiation may discourage these types of improvements.

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Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law Blog: Biosimilars

The gray box at the top of the document at this link shows the change in position. Second, the memo makes it clear that the intended investigation targets are persons and entities providing medical care, but the statutes own definition of FGM excludes such care. FGM is defined as any procedure performed for non-medical reasons.