The U.S. Food and Drug Administration announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost “generic” alternatives to biologic drugs that treat serious and chronic diseases. In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.
Each recipient has a product with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization, addressing a public health crisis, boosting domestic manufacturing, or increasing medication affordability with Most Favored Nation pricing.
From KFF Health News Network – Their latest podcast, What the Health, It’s not yet clear how the federal government shutdown will end, but Democrats are continuing to draw attention to the issue they are promoting — the coming expiration of additional subsidies for Affordable Care Act insurance plans. Some Republicans are now going public with their worries about the huge cost increases many of their constituents face.
From KFF Health News Network – Their latest podcast, What the Health, Just days after his firing of the brand-new director of the Centers for Disease Control and Prevention, a defiant Robert F. Kennedy Jr., the U.S. secretary of health and human services, defended that action and others before a sometimes skeptical Senate Finance Committee.
By ShaAvhrée Buckman-Garner MD PhD & Mary Thanh Hai MD – FDA Advances Drug Development Innovation by Establishing ISTAND as Permanent Qualification Program – The FDA is excited to announce that our Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program has transitioned to a permanent drug development tool (DDT) Qualification Program.
Health IT product news from Motive, Auxira Health, Wolters Kluwer Health, Verato, Cantata Health Solutions, 1upHealth, Wisp, ConneXor Community, Curative, Experity, HerMD, FDA, Huma Therapeutics, Amplity, Ambience Healthcare, TalkDesk, Intelerad Medical Systems, SurgiQuality, Testsigma, Tempus AI, Andor Health, Relatient and more.
From KFF Health News Network – Their latest podcast, What the Health, After narrowly passing a budget resolution this spring foreshadowing major Medicaid cuts, Republicans in Congress are having trouble agreeing on specific ways to save billions of dollars from a pool of funding that pays for the program without cutting benefits on which millions of Americans rely.
The U.S. Department of Health and Human Services and U.S. Food and Drug Administration announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply—a significant milestone in the administration’s broader initiative to Make America Healthy Again.
From KFF Health News Network – Their latest podcast, What the Health, A week into the reorganization of the Department of Health and Human Services announced by Secretary Robert F. Kennedy Jr., the scope of the staff cuts and program cutbacks is starting to become clear.
From KFF Health News Network – Their latest podcast, What the Health, The second Trump presidency launched with a bang at the Department of Health and Human Services, where a traditional pause on public communications was expanded to an effective stoppage of scientific work, as health agencies were ordered to cancel meetings, travel, and efforts on outside publications.
By Robert M. Califf MD – One of the most alarming changes is the recent decline in life expectancy in our country, largely due to the cumulative impact of CCDs, combined with excessive rates of suicide, drug overdose and gun violence, and, of course, COVID-19. How can it be that our prowess in technology is not translating into better health and longevity for the American public?
By Robert M. Califf MD – Since launching our Overdose Prevention Framework in August, 2022, the FDA has taken some important steps to address the opioid overdose crisis. I’d like to catch up with you about opioid use disorder, and efforts we’re taking to mitigate this ongoing health condition.
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