Regulatory Affairs, SaMD & Digital Health Expert
I like to write about people, the places they live and the things with which they choose to surround themselves. Here are some of my favorite pieces that made it into Article.
Key Takeaways The Department of Health and Human Services (HHS) is investigating Hims & Hers for potential federal law violations. The investigation follows the FDA’s announcement to tackle the marketing of unapproved, compounded weight loss drugs. The FDA aims to restrict certain active ingredients used in these compounded medications to protect consumer safety. What’s Happening …
Key Takeaways Trump administration officials blocked an FDA effort to expedite approval for a psilocybin treatment aimed at severe depression. The decision points to potential disagreements within the administration regarding health policies. Only one treatment, Compass Pathways’ psilocybin, was vetoed from the FDA’s list of prioritized medicines. What Happened? In an interesting turn of events, …
Key Takeaways Richard Pazdur, a former FDA regulator, raised concerns about diminishing boundaries between political influence and drug review processes. He highlighted a lack of transparency in a new voucher program that expedites drug reviews based on political decisions. Pazdur emphasized the troubling dismantling of 25 years of progress in drug regulation during his talk …
FDA Pauses Gene Therapy Trials After Child Develops Brain Tumor The FDA has recently paused trials for two experimental gene therapies developed by Regenxbio. This decision came after a concerning incident where a child participating in the trial developed a brain tumor. The therapies in question aim to address mucopolysaccharidosis type I and type II, …
The Future of Personalized Gene Editing: What Lies Ahead When Baby KJ made headlines last year as the first recipient of a personalized gene-editing treatment, it sparked a big question: How can we help more children like KJ? In November, just six months after KJ’s groundbreaking journey began, two prominent figures from the Food and …
TL;DR: Personalized medicine is revolutionizing healthcare by offering tailored treatment plans based on an individual’s unique genetic makeup, lifestyle, and environment. This approach promises more effective treatments with fewer side effects, shifting the focus from a “one-size-fits-all” strategy to more personalized care. As technology advances, integrating genetic profiling and data analytics into standard medical practices …
The Future of Radiology: AI Takes on Multiple Findings Artificial intelligence (AI) is transforming the way we think about healthcare, particularly in the field of radiology. While you may have heard about bundling services like your streaming platforms, AI is now bundling its capabilities too. New tools are getting FDA approval to evaluate multiple findings …
Key Takeaways The FDA is changing its oversight of cell and gene therapies to be more flexible. This flexibility may speed up the development of important new therapies. However, loosening regulations raises risks for patients and the entire CGT field. Stakeholders are watching closely to understand the impact of these changes. It’s essential to balance …
Understanding the FDA’s Breakthrough Device Program: What You Need to Know The FDA’s breakthrough device program is making waves in healthcare, and it’s essential to understand what this means for patients and providers alike. With the rapid approval of medical devices, there are both promising opportunities and potential pitfalls. Here’s a quick overview of what …
Key Takeaways The FDA has relaxed requirements for clinical decision support (CDS) tools, allowing certain AI tools to enter clinics without stringent approval. New AI advancements include a pilot program in Utah for automated prescription refills and OpenAI’s ChatGPT Health for personalized responses. These developments aim to improve patient access to health advice and streamline …