Democrats concede to clean user fee agreements to fund FDA; regulators roll out new guidance on medical devices

Biotech turns to new viruses to advance gene therapy; the hazards of clinical research in the Dobbs era ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ 

Sponsored by      In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices By Casey Ross Alex Hogan/STAT The FDA has published a list of AI tools that should be regulated as medical devices, including those that alert about sepsis. Read More Opinion: The Inflation Reduction Act will help the U.S. achieve maximum vaccine access and uptake, but access gaps remain By Richard Hughes IV Adobe The Inflation Reduction Act helps close the gaps in needed vaccinations, but more must be done to extend vaccine access to every American. Read More Sponsor content by Janssen Immunology A 3-step approach to equitable care in immunology Over the past two decades, scientific innovation has translated into real progress for people living with immune-mediated diseases. Yet disparities in care may prevent people of color from benefitting from the full potential of that innovation. In the journey to shaping an equitable future in immunology, three steps are key. Learn more about the steps the healthcare industry can take to drive health equity in immunology. 'It is sinking us even further': STI clinics, already stretched thin, strain under weight of monkeypox response By Andrew Joseph Mary Altaffer/AP Clinics that specialize in STI and HIV/AIDS care were already short on resources as STI rates spiked. And now there's monkeypox. Read More Tuesday, September 27, 2022       1 Exchange Pl, Suite 201, Boston, MA 02109 ©2022, All Rights Reserved. I no longer wish to receive STAT emails Update Email Preferences | Contact Us | View In Browser