Regulatory Affairs, SaMD & Digital Health Expert
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 …
Understanding the Growing Buzz Around Testosterone Testosterone is gaining attention in health conversations lately, especially from the Department of Health and Human Services. If you’ve ever wondered about testosterone replacement therapy or how diet might affect your hormone levels, you’re not alone. Let’s break it down so it makes sense. Key Takeaways Increased Access: There …
Understanding Menopausal Hormone Therapy: What Women Need to Know Navigating the world of health information can be overwhelming, especially on social media. If you’re a woman transitioning through menopause, you may have seen claims that a single therapy can handle everything from wrinkles to heart health. Let’s break down the hype surrounding menopausal hormone therapy …