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A federal judge has cleared Pfizer’s $345 million settlement resolving claims the drugmaker overcharged for its EpiPen epinephrine self-injector for treatment of severe allergic reactions. Read More
The FDA’s Safer Technologies Program (STeP) for Devices provides similar agency resources and priority review to sponsors whose devices do not meet the criteria for breakthrough status. Read More
HHS withdrew a temporary policy yesterday that directed the FDA not to enforce its premarket review requirements for laboratory developed COVID-19 tests — an emergency policy that was put in place to get tests quickly into use during the pandemic. Read More
It is important that viral transport media “are appropriately designed and validated prior to distribution to ensure that the transport medium will preserve the viral particles without meaningful degradation that could lead to inaccurate test results,” the agency said. Read More
Equipment operators and items brought into a plant are the two chief reasons for contamination in manufacturing clean rooms, said disinfecting expert Jim Polarine during an FDAnews webinar hosted last week. Read More
Exogenesis’ nanoMesh hernia repair device caused less inflammation than a control implant mesh during evaluations 14 and 28 days after implant, the company says. Read More
The Department of Health and Human Services (HHS) said Wednesday it will spend $650 million in American Rescue Plan funds to strengthen manufacturing capacity for COVID-19 diagnostics, through rapid point-of-care molecular tests, and to increase public access to them. Read More
One of the complaint unit’s chief responsibilities is to maintain complaint files, which are the records documenting all analysis conducted and actions taken when a company receives a complaint about a device. Read More
As part of a major reorganization, General Electric is spinning off its GE Healthcare division as a publicly traded company, the corporation announced this week. Read More
Device trade association AdvaMed has told the federal government that the worldwide shortage of semiconductors continues to create major problems for the industry. Read More