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.
FDA Now Offers Daily Updates on Adverse Drug Events The Food and Drug Administration (FDA) recently made a significant change in how it shares information about drug safety. Starting now, the FDA will publish reports on adverse events related to drugs and biological products every day. Previously, this information was only updated once every few …
Understanding the Impact of FDA Decisions on Biotech Trials In the world of biotechnology, regulatory decisions can have ripple effects that extend beyond the immediate concern. Recently, a notable case involved the FDA’s rejection of a skin cancer therapy developed by Replimune Group. This decision didn’t just affect Replimune; it led to the abrupt pause …
The Importance of U.S. Involvement in Global Medical Standards When U.S. regulators are not part of the conversation while global medical standards are established, it carries significant risks for patient safety, medical innovation, and cybersecurity. This issue isn’t just a matter of regulations; it directly impacts the quality of healthcare we receive. Key Takeaways: U.S. …
Are Investors Losing Faith in mRNA Biotechs? Investors are always on the lookout for the next big thing in biotech, and mRNA technology has had its moment in the spotlight. However, recent trends suggest that enthusiasm may be waning. This week’s episode of “The Readout LOUD” dives into this topic and much more. Key Takeaways: …
The Urgent Need for Including Pregnant Women in Drug Research Pregnancy is a unique time in a woman’s life, filled with excitement but also uncertainty, especially when it comes to taking medications. It’s essential to address the significant gaps in drug safety research for pregnant women. Here’s what you need to know. Key Takeaways Pregnant …
Key Takeaways FDA leaders are actively working to restore normal operations after recent disruptions. Employees have expressed concerns over staffing, funding for research, and the shift in meeting protocols. The FDA is committed to retaining staff and filling vacant positions while encouraging employee feedback. Navigating Change at the FDA: What’s Happening Inside? The FDA is …
The Case for Medicare Covering FDA-Approved Medical Innovations In a recent interview, FDA Commissioner Marty Makary suggested a straightforward but impactful reform: Medicare should automatically cover devices labeled as breakthrough by the FDA. In a health care system bogged down by bureaucracy, this idea stands out as both sensible and necessary. Key Takeaways: Medicare needs …
I. Executive Summary The landscape of medical devices is undergoing a profound transformation, driven significantly by the emergence and rapid expansion of sensor-based digital health technology (sDHT). This report provides a comprehensive analysis of FDA authorizations for sDHT devices from 2015 to 2025, revealing a sector characterized by robust growth, strategic diversification, and a pronounced …
Is Flouride in Our Water a Health Concern or Medical Freedom? Robert F. Kennedy Jr. has stirred considerable debate by advocating for the removal of fluoride from drinking water, framing it as a matter of personal choice and medical freedom. This issue has significant implications for parents, health professionals, and local communities. Key Takeaways: Kennedy …
Understanding Mental Health During Pregnancy: Why Treatment Matters Navigating pregnancy can be a whirlwind of emotions. For some, it’s a time filled with joy and anticipation; for others, it’s a struggle with mental health challenges like anxiety and depression. This is a reality faced by many, including Tinelle Windham, who experienced intrusive thoughts and panic …