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.
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 …
Key Takeaways Tracy Beth Høeg, now the FDA’s acting director, has past concerns about decision-making based on belief rather than science. During her time as a scientific adviser, some FDA staff have questioned her objectivity. The role requires careful review of scientific evidence relating to medical treatments. A Journey from Concern to Leadership In 2008, …
Regenerative Medicine: What You Need to Know It’s hard not to notice the excitement surrounding regenerative medicine. Clinics boast about “miracle injections” and “next-generation cell therapies” that claim to heal joints, reverse arthritis, and even restore youth. For those in pain or looking to reclaim lost vitality, it’s tempting to believe that we are on …
Understanding the Controversial CDC Grant for Hepatitis B Vaccine Research The CDC has recently approved a $1.6 million grant to researchers at the University of Southern Denmark. This funding aims to study the effectiveness of hepatitis B vaccines, but it has sparked some debate among experts and the public. Let’s break down what this means …
Cytokinetics Achieves Milestone with U.S. Drug Approval Cytokinetics, a biotech company, has officially secured its first drug approval in the United States after 27 years of work. This significant achievement highlights the challenges and triumphs in the world of drug development. Here’s what you need to know about this exciting news. Key Takeaways Drug Approval: …
Understanding the Impact of Food Safety Cuts The recent outbreak of infant botulism linked to ByHeart formula has highlighted a critical issue: the vulnerability of our food supply. This incident serves as a wake-up call about the fragility of food safety systems in the U.S. Additionally, recent federal budget cuts might leave consumers at greater …
Key Takeaways The FDA is facing significant leadership challenges ahead of 2026. High-profile departures and internal conflicts have lowered employee morale and stability. The future of FDA Commissioner Marty Makary is uncertain, raising concerns among key officials. The Food and Drug Administration, or FDA, is navigating a tricky landscape as it approaches 2026. Recent months …