We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Manufacturers of cyber devices must have a plan to keep those devices secure for the product’s entire lifecycle, and sponsors of nonprescription drugs can include some minor labeling changes on an annual report, according to two new draft guidances issued by the FDA. Read More
A ventricular pumping system for heart failure patients could unexpectedly stop and start, prompting a correction recall from the manufacturer and a Class 1 recall announcement from the FDA. Read More
The recent glut of AI-fueled dermatology apps claiming to help consumers diagnose, track or treat skin conditions actually lack supporting evidence and don’t offer input from clinicians or dermatologists, according to a study published in JAMA Dermatology. Read More
Drugs for cognitively and functionally normal people who have the pathophysiologic changes of Alzheimer’s disease (AD) could be approved on a single biomarker outcome, according to the FDA’s new draft guidance on drug development for early AD. Read More
Manufacturing and distributing adulterated drugs for nearly a decade — some of which originated in a foreign country without FDA authorization — has brought $3.5 million in penalties to a Pennsylvania generic pharmaceutical company. Read More
During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Medtronic Neurosurgery’s recall of its Duet External Drainage and Monitoring System (EDMS) catheter tubing due to a potential for the catheter disconnection from the patient line stopcock connectors has been identified as a Class I recall by the FDA. Read More
Real-time communication between sponsors and regulators is a top priority for Nicole Verdun, the recently installed Super Office director for the Office of Therapeutic Products (OTP). Read More
The Senate passed a fiscal 2024 funding package late Friday that includes a total of $6.72 billion for the FDA, which was signed by President Biden on Saturday. Read More
President Biden wants to extend the cost-capping Inflation Reduction Act (IRA) far beyond Medicare recipients and their prescriptions, and allow Medicare to negotiate the prices of 500 drugs over the next 10 years, he said during his State of the Union (SotU) address on Thursday night. Read More
Rather than handing out the approval Lilly was hoping for, the FDA will put donanemab, the company’s antiamyloid contender, through its paces in an upcoming advisory committee meeting. Read More
The European Commission (EC) has released a draft regulation spelling out how member states should implement the pending EU law on health technology assessment (HTA), due to go into effect early next year. Read More