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Late Monday afternoon, the FDA announced its $7.2 billion budget request as part of President Biden’s $7.3 trillion fiscal 2025 proposed budget, which was released Monday. Read More
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
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
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
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