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
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.
FDA Grants EUA To First OTC Test That Detects COVID-19, Flu, RSV
The US agency has issued an emergency use authorization to Labcorp for its over-the-counter test that detects COVID-19, flu and respiratory syncytial virus.
US To Share Its COVID-19 Technologies With World, Biden Says
During the second global COVID-19 summit, US President Joe Biden pledged to share essential technologies across the globe to fight the pandemic.
Industry Experts Give FDA’s Pre-Cert Program Thumbs-Up
A panel of industry experts gave the US FDA’s Digital Software Precertification Program the thumbs-up during a MedCon session.
Skip Skippack COVID-19 Test, FDA Warns
The Food and Drug Administration has designated the recall of a COVID-19 test from SML Distribution LLC as class I, the US agency’s most serious classification.