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Califf: Diabetes, Weight Loss, Alzheimer’s Drugs Could Be “Major Game Changers”

Pharma Leaders

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

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Latest nitrosamines recall spotlighting need to control pharmaceutical impurities

Quality Matters

Starting in 2018, concerning levels of these impurities were found in commonly prescribed medicines for blood pressure, diabetes, and other conditions. FDA and other global regulatory agencies have issued public health alerts and guidance documents for manufacturers.

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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair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

Clarify What Information is Sought from Speakers Report on Data Utilization Host Educational Webinars Before Listening Sessions Market as Stakeholder Listening Sessions if They Have Broader Representation Improve the Structure of the Listening Sessions. Finally, we encourage CMS to consider a longer time horizon for the submission of data.