Brian Bossetta
Senior Writer, US Policy & Regulation
Brian holds a BA in history from Loyola University of New Orleans, is a die-hard Saints fan, and loves running, classical music and jazz. He lives with his wife, Caroline, in New York’s magnificent Hudson Valley.
Latest From Brian Bossetta
Urgent Recall Of Cornea Patch Grafts Due To HIV Concerns
CorneaGen has issued an urgent recall of its Scleral Patch Grafts after discovering they were created using tissue from a donor who tested reactive for HIV.
Pew Responds To Draft Legislation Creating Regulatory Oversight Of Lab Developed Diagnostics
The time to create a flexible, risk-based regulatory system for all in vitro diagnostics is now, Pew tells US lawmakers, and offers suggestions to improve draft legislation that aims to do just that.
BARDA Releases Five-Year Strategic Plan
The Biomedical Advanced Research and Development Authority says lessons learned from the pandemic has better prepared the agency to respond to future health emergencies, including a new infectious disease division.
Medicare Proposes NTAP For Breakthrough Treatment Of Spinal Condition
US Medicare has granted a new technology add-on payment (NTAP) for an innovative technology designed to treat adult spinal deformity.
First EUA In US For OTC Test To Detect COVID-19, Flu, RSV Granted To Labcorp
Agency issued an emergency use authorization to Labcorp for its OTC that detects COVID-19, flu and respiratory syncytial virus.
Senate Bill Establishes Greater Regulatory Oversight Of Lab Developed Tests
Draft legislation out of the US Senate Health, Education, Labor and Pensions (HELP) Committee gives the FDA authority to regulate certain in vitro diagnostics known as laboratory developed tests.