Exclusive: FDA staff struggle to meet product review deadlines after DOGE layoffs
Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...
Fierce Biotech7h
FDA’s novel medical device clearances slow to a crawl
According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...
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RFK Jr. brings FDA under tighter control with HHS workforce cuts
Around 3,500 employees are on the chopping block at the Food and Drug Administration, but they don’t yet know who they are.
ADLINK San Jose Manufacturing Center (SJMC) Achieves FDA Registration as a Contract Manufacturer, Enhancing Support for Medical Device Customers
ADLINK Technology today announced that its San Jose Manufacturing Center (SJMC), a California facility has secured ...
MassDevice5h
RFK Jr. plans thousands of layoffs at FDA and other HHS agencies
Trump and RFK Jr. plan to cut thousands of employees from the FDA and other agencies within the Department of Health and ...
FDA classifies recall of Medtronic embolization devices as 'most serious'
The U.S. Food and Drug Administration on Tuesday classified the recall of Medtronic's embolization device as "most serious", ...
Soleno Therapeutics execs reap stock windfall after FDA approves rare disease drug
Soleno Therapeutics' FDA-approved drug for Prader Willi Syndrome triggers executive stock bonuses as the company's value ...
JD Supra1d
Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...
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HHS Reorganization To Slash 20,000 Jobs, Including 3,500 at FDA
Today, the Dept. of Health and Human Services (HHS) announced “a dramatic restructuring” that will slash its total payroll by ...
Nearly a third of FDA medical device adverse events reported late: study
Reports on medical device adverse events widely exceed FDA deadlines, according to a recent study published in the BMJ. Read ...
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Reading the Tea Leaves in FDA's AI-Enabled Device Guidelines
While recent draft guidance from the Food and Drug Administration pertaining to artificial intelligence-enable medical ...