Regulatory Affairs, SaMD & Digital Health Expert
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 …
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 …