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The FDA has laid out its current thinking on the adhesive performance and irritation potential of generic transdermal and topical drug delivery systems and clarified recommendations for designing safety and efficacy studies for these products, in a pair of revised draft guidances. Read More
Multiple devices and digital behavioral interventions have been approved or are in the works to help patients suffering from opioid use disorder (OUD), says FDA Commissioner Robert Califf, but obstacles such as a high failure rate and proof of efficacy stand in the way of wider adoption. Read More
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