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. Source:…

In an effort to increase industry dialogue around best practices for benefit-risk assessments, AstraZeneca (AZ) has publicly shared the structured benefit-risk (sBR) assessment framework it employs across its drug development…

A study of drugs granted accelerated approval by the FDA between January 2012 and July 2021 found that more than half of the required confirmatory trials missed their deadlines. Source:…

Problems related to written procedures occupy three spots in the FDA’s list of top 10 observations made in drug manufacturer inspections year after year: “procedures not in writing, fully followed,”…

AbbVie and Johnson & Johnson (J&J) are voluntarily withdrawing accelerated approval for their blockbuster oncology drug Imbruvica (ibrutinib) for two blood cancers following disappointing confirmatory trial results. Source: Drug Industry…

The Center for Biologics Evaluation and Research (CBER)’s ability to hire and retain staff will be a key challenge for fiscal 2024, according to Peter Marks, the center’s director, who…

Part 2 of our two-part series on the impact of artificial intelligence (AI) on medical devices focuses on the significant regulatory challenges. Source: Drug Industry Daily

A federal appeals court has cleared the way for PhRMA’s complaint against Minnesota’s plan to have manufacturers provide insulin for free to move forward. Source: Drug Industry Daily

Source: Drug Industry Daily

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…