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While Congress may have ended the “national emergency related to the COVID-19 pandemic” with a joint resolution President Biden signed into law on Monday, the public health emergency (PHE) declared by HHS Secretary Xavier Becerra will remain in effect another month. Read More
Bookshelves in Washington are filled with expert reports that have never been read and with recommendations that have never been implemented. Read More
Philips Respironics has once again recalled some of its DreamStation continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, this time for a potential programming flaw. Read More
The Department of Justice (DOJ) has charged three former executives of Magellan Diagnostics for allegedly concealing a device malfunction that could produce inaccurately low lead test results, to improve Magellan’s bottom line while positioning the company to be acquired. Read More
AdvaMed has submitted an amicus brief to the U.S. Supreme Court in support of two supermarket chains accused of violating the False Claims Act by misreporting their drug prices, arguing that the errors were due to complex and sometimes conflicting regulations. Read More
FDAnews welcomes to its new editorial advisory board seven thought leaders with deep experience in the drug, device and clinical research industries. These seven experts are at the top of their field and will help provide our readers with even greater depth and analysis of drug and device industry news and trends. Read More
The Centers for Medicare and Medicaid Services (CMS) published a similar final rule in January 2021 that provided four years of Medicare coverage for innovative medical devices but later rescinded it later based on safety concerns. Read More