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The FDA has deemed Fresenius Kabi’s March 8 recall of its Ivenix Infusion System as Class I, the most serious type of recall, as use of the device may cause serious injuries or death. Read More
The FDA would like to have the regulatory authority to restrict new opioid approvals to those that are safer than already-approved and marketed opioids, Commissioner Robert Califf told senators at a hearing discussing the agency’s 2024 budget request. Read More
In a new interview posted to its website, top officials in the FDA’s Center for Drug Evaluation and Research (CDER) highlight key benefits of the Guidance Snapshot Pilot Program, which aims to make the agency’s often byzantine and highly technical guidance documents more accessible to a wide range of stakeholders. Read More
The FDA has slapped Abbott Point of Care Canada with a warning letter for marketing a product with design and component changes without applying to the agency for clearance or approval. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause analysis. Read More
Prolonged treatment time and maximum amyloid depletion appear key to slowing the cognitive decline of Alzheimer’s disease, researchers reported at the International Conference on Alzheimer’s & Parkinson’s Disease earlier this month. Read More
The top citations in FDA warning letters tend not to change radically from one year to the next, but the agency’s warning letters for fiscal 2022 hint at an increased focus on component testing and contractor oversight. Read More
Philips has struck a deal with Amazon Web Services (AWS) to offer its healthcare picture archiving and communication system on AWS’ artificial intelligence (AI)-driven cloud computing platform for an undisclosed financial amount. Read More
Going back to pre-2016 restrictions around the abortion drug Mifeprex — which a federal appeals court now seeks to do — would set off a cascade of problems that could take months, if not longer, to work out and cause the drug to be misbranded in the meantime, according to FDA Principal Deputy Commissioner Janet Woodcock. Read More
The FDA has approved Omisirge (omidubicel-onlv), Gamida Cell’s first-in-class allogeneic umbilical cord-blood stem cell treatment for blood cancers, which carries a unique twist that increases their immune-boosting potential. Read More
Merck announced Monday it will acquire Prometheus Biosciences in a nearly $11 billion deal expected to greatly expand the drugmaker’s portfolio of treatments for autoimmune diseases. Read More