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As two dueling lawsuits over the FDA-approved medical abortion drug mifepristone appear headed to the U.S. Supreme Court, hundreds of drugmakers say Friday’s ruling in the Texas case is an overstep that could weaken the federal agency and hamper future drug development. 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
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 process. Read More
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. Read More
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,” “absence of written procedures” and “written procedures not established/followed.” Together, they represent 41.2 percent of all observations cited on FDA Form 483s to drugmakers in 2022. Read More
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. Read More
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 spoke last week at an Alliance for a Stronger FDA webinar. Read More
Part 2 of our two-part series on the impact of artificial intelligence (AI) on medical devices focuses on the significant regulatory challenges.Read More
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. 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
The FDA has withdrawn its approval of Makena, Covis Pharmaceutical’s drug to reduce the risk of pre-term birth in at-risk women, citing the lack of a favorable postmarket benefit-risk assessment and ending Covis’ hopes for an “orderly wind-down” period. Read More