Life Spine To Pay Almost $6M In Kickback Settlement
The spinal implant company and two executives have agreed to pay almost $6m to resolve a health-care fraud case. Life Spine Inc. reportedly paid out almost $7m in illicit consulting and licensing fees between 2012 and 2018.
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FDA Finalizes Guidance Documents Aimed At Easing Post-Pandemic Regulatory Transitions
The documents describe the US agency’s preferred approach toward products cleared under EUAs or other alternate approaches during the COVID-19 public health emergency.
COVID-19 EUAs To Stay Active After Public Health Emergency Ends
Authorizations in place for diagnostics, personal protective equipment, and other products cleared for emergency use during the pandemic will remain in place until the potential for an outbreak no longer exists or products receive traditional clearances, according to a Federal Register notice issued by HHS this week.
News We’re Watching – FDA Mammography Update, SVB Collapse, Zoll's Data Breach, And More
News we are keeping an eye on this week includes the FDA’s first traditional market authorization for a COVID-19 test and its approval of a new neurological diagnostic. The agency also updated its device shortage list and revised mammography guidelines.