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Health professionals speak out against the new nuclear arms race

Common Sense Family Doctor

At last month’s World Health Assembly, the World Health Organization (WHO) overwhelmingly passed a resolution to update Cold War era reports on the health and environmental effects of nuclear weapons and war by 2029. The United States was absent, having withdrawn from the WHO in January.)

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A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law Blog

While the dates have been written in the law, the previous extensions provided a reasonable hope that the program would continue. This bill would extend the designation deadline until September 30, 2029, a five-year extension (and would require yet another GAO report). After all, this is what incentives are for.

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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance.

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Landmark Drug Pricing Bill Set to Become Law; HP&M Releases Summary Slide Deck

FDA Law Blog

The number will begin in 2026 with 10 drug covered under Medicare Part D and will increase annually to 20 Part B and 20 Part D drugs by 2029 and thereafter, with the selected drugs accumulating from year to year. Manufacturers receive no benefits in exchange for the inflation rebates.