In Vivo is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Brian Bossetta

Senior Writer, US Policy & Regulation

New York, NY

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 healthcare. 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

FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices

In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.

FDA Guidance Documents

FDA Updates COVID-19 Test Policy; Shifts Focus From EUAs

As part of a policy revamp, FDA encourages COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.

OTC Devices FDA

FDA Updates COVID-19 Test Policy; Shifts Focus From EUAs

As part of a policy revamp, the US FDA is encouraging COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.

FDA Policy

Another Class I Recall For Philips BiPAP Machines

The US FDA has labelled as class I an August recall of Philips Respironics BiPAP machines due to the potential of hazardous chemicals being inhaled by the user or shutting down the machines.

FDA Regulation

FDA Issues Guidance To Protect Children Enrolled in Clinical Trials

The US FDA has published a draft guidance outlining its current thinking on ethical considerations for clinical trials of medical products, including devices, that enroll children.

FDA Pediatrics

ATA Launches Coalition To Advance Telehealth Patient Advocacy

The American Telehealth Association has created a coalition with the mission of ensuring patients have a voice in the future of telehealth.

Telehealth Policy
See All
UsernamePublicRestriction

Register