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.
The FDA has established an Artificial Intelligence Program with a focus on six research topics that delve into the far-reaching implications of medical devices powered by AI and machine learning. Read More
The House’s fiscal 2025 Agriculture-FDA bill, released Monday, keeps spending almost flat, providing the FDA with $6.75 billion in total funding, short of the agency’s $7.2 billion budget request. Read More
The FDA has deemed two recalls as Class I — Medline Industries for issues with its Sub-G Endotracheal Tube and Abbott for yet another issue with its HeartMate 3 Left Ventricular Assist System. Read More
AdvaMed notched a victory last Friday when the US Court of Appeals ruled in its favor in the latest saga over what the association describes as preventing “unauthorized and unregulated repair companies from hacking into life-saving medical devices.” Read More
A New Jersey federal judge has ordered Teva Pharmaceuticals to remove from the Orange Book five patents on its ProAir HFA asthma inhalation device, clearing the way for Amneal Pharmaceuticals to launch a generic version. Read More
Understanding what documents you must provide to the FDA during an inspection — and what’s off limits to the agency — is a key to timely and effective responses, according to inspections expert David Chesney. Read More
As the second session of the 118th Congress begins, FDAnews will track important 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