The U.S. Food and Drug Administration is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2028 through 2032. The current legislative authority for MDUFA expires on Sept. 30, 2027.
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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.
This month’s AI report includes news and updates from Sword Health, TeleTracking, Palantir, Pacific AI, Coalition of Health, H1, Veda, ArcheHealth, Lumeris, Biostate Ai, SurgiQuality, Huma, FDA, Amplity, Ambience Healthcare, Experity, Talkdesk, Cognizant, & more.
The “Make Our Children Healthy Again Assessment” report exposes a range of contributing factors—including poor diet, accumulation of environmental toxins, insufficient physical activity, chronic stress, and overmedicalization.
The initiative is part of a broader federal effort to reduce regulatory burdens and increase transparency, in alignment with President Trump’s Executive Order 14192, “Unleashing Prosperity Through Deregulation.”
In 2024, the healthcare industry witnessed groundbreaking innovations that redefined patient care, medical research, and technological integration. Here we explore some of the most impactful healthcare breakthroughs of 2024, shedding light on how they are shaping the future of medicine.
By Patrizia Cavazzoni MD & Peter Marks MD PhD – Through the Hub, we plan to foster a community at the FDA for open dialogue and knowledge sharing to identify new approaches to drug and biologic development and overcome hurdles that have traditionally impeded progress for rare disease treatments.
By Inga Rose & and Aaron Schlum – On May 6, FDA published a final rule that will change the way laboratory-developed tests are regulated. The rule phases out the agency’s general policy of “enforcement discretion” and mandates that, across five stages within the next four years, LDTs will be beholden to the same regulatory requirements as in vitro diagnostics.
By Patrizia Cavazzoni MD & Peter Marks MD PhD – An estimated 10,000+ rare diseases affect more than 30 million people – approximately one out of every 10 people – in the U.S., and about half of these people are children. Many rare conditions are life threatening, and most do not have approved treatments.