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.
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 …
Key Takeaways A new FDA program is allowing political influence over drug reviews. Historically, reviews were managed by career scientists to prevent interference. High-ranking officials are involved in deciding which drugs get expedited reviews. This shift raises concerns about the safety and efficacy processes for medications. Introduction The world of pharmaceuticals can be complex, and …
Understanding the Impact of Anti-Science Rhetoric on Healthcare Key Takeaways Open conversations are crucial between healthcare providers and patients regarding vaccination and treatment. Emotional connections can enhance patient compliance better than data alone. Medical communities must engage in open, respectful discussions on controversial topics. Recognizing and addressing patients’ fears can improve healthcare experiences. The role …
New Oral Antibiotics for Gonorrhea: What You Need to Know A new oral antibiotic has just been approved to treat gonorrhea, marking a major milestone in the fight against this common sexually transmitted infection. This is the second time in recent days that a new treatment has gained FDA approval. Let’s break down why this …
The FDA’s Confusing Approach to Oversight: What’s Going On? Navigating the world of medicine and public health can feel like trying to follow a complicated map—especially when it comes to what the Food and Drug Administration (FDA) decides to approve and how much scrutiny it gives different products. It seems like the FDA is playing …
Important Safety Alert: Issues with Certain Glucose Monitor Sensors The U.S. Food and Drug Administration (FDA) has issued a serious warning about specific glucose monitor sensors from Abbott Diabetes Care. These devices, crucial for individuals with diabetes, have been linked to at least seven deaths and more than 700 injuries. It’s essential for users to …
FDA Updates Approval Process: One Clinical Trial Instead of Two In an important shift, the Food and Drug Administration (FDA) plans to change its requirements for medical product approvals. Instead of the usual two clinical trials, the FDA will primarily consider just one trial, as revealed by FDA Commissioner Marty Makary. This change could streamline …
New FDA Memo Raises Concerns Over Covid Vaccine Regulation In a recent email, Vinay Prasad, head of the FDA’s vaccine division, made a startling claim: at least ten deaths in children may be linked to Covid-19 vaccines. This assertion, sent to his staff, has raised eyebrows among experts who find the lack of supporting data …