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.
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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.
By Hilary Marston MD MPH & Kevin Bugin PhD – Breakthroughs in science and technology are advancing innovation in more areas of medicine, providing novel treatment options for patients. The scientific community has a deepening understanding of disease and human biology, and of the enormous potential afforded through new technologies.
This month’s AI report includes news and updates from eClinicalWorks, Viz.ai, NICO Corp, ModMed, Medtronic, Greenway Health, Nabla, Innovaccer, Accolade, Inc., GE Healthcare, HubStar, Wolters Kluwer, Eko Health, DrFirst, Nextech, & more!
By Robert Califf – What we now call real-world data (RWD) have been used for years in medical product development to inform study design and endpoint selection, identify potential participants and trial sites, and assess safety in the post-marketing setting.