Brian Bossetta
Senior Writer, US Policy & Regulation
After moving to New York from his hometown of New Orleans, Brian worked on the East End of Long Island covering news, politics and the military. He has since covered the diamond and jewelry industries and most recently pharmacy and health care. His experience also includes freelance reporting and photography contributed to the New York Times.
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
Despite Noisy Debut, Report Finds Impact Of OTC Hearing Aids Still Muted
More than a year after the FDA created a new rule allowing hearing aids to be sold over the counter and directly to consumers, a government report finds the category has not yet made the impact many were expecting.
FDA Offers Draft Guidance For Developers Of Drug Delivery Devices
The US FDA has published draft guidance for developers of drug delivery devices listing recommendations related to device design outputs essential for establishing and assessing the performance of their products.
Philips Disputes Additional Deaths Linked To May Recall Of Breathing Machines
The US FDA is reporting dozens more additional deaths associated with a May recall of Philips ventilators than initially reported. The company says it stands by its original number of seven and has reached out to the FDA.
FDA Explains Reasons For Delaying, Limiting Or Refusing Inspections In Final Guidance
The US FDA has issued its final guidance defining manufacturer behaviors it deems as hampering the agency’s ability to conduct an inspection. In a previous draft guidance, the agency expanded its longstanding policy on inspections of drug companies to include device makers as well.
News We’re Watching: Boston Sci Buys Silk Road Medical; EOFlow Injunction Blocked; LDT Compliance Dates Announced
This week, Boston Scientific agreed to pay $1B+ for stroke prevention device firm Silk Road Medical; the FDA asked for feedback on patient safety for non-device medical software; and a former medtech CEO was sentenced to six years for her part in a phony device scheme.
FDA Finalizes Definitions Of Delaying Or Denying Inspections
The US FDA has issued its final guidance defining manufacturer behaviors it deems as hampering the agency’s ability to conduct an inspection. In a previous draft guidance, the agency expanded its longstanding policy on inspections of drug companies to include device makers as well.