Regulatory Affairs, SaMD & Digital Health Expert
Key Takeaways Recent FDA inspections revealed serious issues at a manufacturing plant acquired by Novo Nordisk. Problems include cat hair, pests, and failures in equipment. These concerns affect not just Novo Nordisk, but also other pharmaceutical companies relying on this facility. Wall Street analysts are watching closely for potential impacts on the drug market. Historical …
Key Takeaways The FDA has approved updated COVID boosters while ending emergency use authorizations for the vaccines. The changes mainly affect availability for children under 5, as vaccines will now only be available to higher-risk groups. Ongoing clinical trials are required for future approvals, aimed at ensuring safety and efficacy. Understanding the Latest Developments in …
The Make America Healthy Again Movement: Where It Stands The Make America Healthy Again (MAHA) movement emerged as a surprising twist in American political health discourse. It was born on a hot August day when Robert F. Kennedy Jr. endorsed Donald Trump after a tumultuous presidential bid. This endorsement was punctuated by a catchy slogan …
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 …