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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. This would include continuous manufacturing, distributed manufacturing, modern aseptic manufacturing equipment and novel analytical methods.

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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Further, “there is little utility in comparing the language of the BIS to that of the AKS.”. Background. Pfizer set the price of tafamidis at $225,000 for each one-year course of treatment.

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Green Practice News: May 2025

My Green Doctor

That’s why our Practice Management program includes a guided, meeting-by-meeting path for helping clinics transition to renewable energy and cut utility bills—without overwhelming staff or adding to your to-do list. The product manufacturers and vendors will need to be active partners as well. Looking for a tailored approach?

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Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. My own work focuses on hospitalization and health utilization over time.

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