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.
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 …
Key Takeaways Adam’s Biotech Scorecard will be on a break for Thanksgiving. Subscribers can expect the next newsletter on December 4. Wishing everyone a happy and festive Thanksgiving! Thanksgiving is just around the corner, and that means a well-deserved break for everyone. If you’re a subscriber to Adam’s Biotech Scorecard, you might have noticed that …
Key Takeaways: Recent changes at the FDA have raised concerns about the integrity of drug reviews. A new priority voucher program allows accelerated drug approvals but raises ethical questions. Negotiations between drug companies and the administration may compromise scientific standards in drug evaluation. The Changing Landscape of FDA Drug Approvals Recently, there was a shake-up …
Key Takeaways The FDA is streamlining its drug review process for companies that earn a Commissioner’s National Priority Voucher. Recently, agency leaders made decisions on drug approvals instead of career officials, raising concerns about political influence. The approval process is now capped at a one-to-two-month timeline, with a focus on efficiency. Understanding Recent Changes at …
FDA Approves Home Use Device for Spinal Cord Injury Recovery Key Takeaways: The FDA has approved home use of the ARC-EX System developed by Onward Medical. The device helps improve mobility for people with spinal cord injuries. Prior clinical trials showed significant improvement in arm and hand function. Patients can now use the device in …
The Future of Personalized Gene Editing: Hope on the Horizon In the world of medical advancements, personalized gene editing is making waves, particularly for children battling rare genetic conditions. Recently, a significant milestone was achieved when a gene editor was designed and used for a baby boy, effectively addressing his severe genetic disorder. This story, …
A New Era in Medicine: Personalized Gene-Editing Treatments The Food and Drug Administration (FDA) is taking significant steps towards making personalized gene-editing treatments a reality. Recently, top officials laid out a pathway for the approval of these groundbreaking therapies, bringing hope to many facing severe genetic disorders. Key Takeaways The FDA is paving the way …
Key Takeaways The FDA is facing challenges in appointing a new leader for its drug center after a sudden departure. Richard Pazdur and Mary Thanh Hai have both declined the role. Deputy FDA Commissioner Sara Brenner has opened the search for candidates within the agency. The FDA’s Search for Leadership The Food and Drug Administration …