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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
Alzheimer’s drugmakers including Biogen, Eli Lilly and Eisai, as well as consumer advocacy group Public Citizen, have characterized a recent FDA guidance on developing drugs for Alzheimer’s as lacking in specifics for later-stage disease progression. 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
The FDA’s 11-person Peripheral and Central Nervous System Drugs Advisory Committee unanimously endorsed both the efficacy and safety of Lilly’s antiamyloid antibody donanemab, saying that people with Alzheimer’s disease and their clinicians should be the ones to decide whether the drug’s modest cognitive benefit outweighs its risk of serious adverse events. Read More
The FDA sent an untitled letter to Achieve Vitality, which markets a product claiming to offer regenerative therapy, for offering an injectable product derived from human umbilical cord for which the company lacks required regulatory approvals. Read More
The FDA has selected seven rare disease therapies to participate in its Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program to accelerate the development of novel drug products through, in part, enhanced communications with the agency. 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
CDER, as part of its Emerging Drug Safety Technology Program (EDSTP) will hold meetings for drug makers and others to discuss their research, development, and use of AI and other emerging technologies in pharmacovigilance. 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
This edition of Quick Notes offers news on medical devices including two continuous glucose monitoring system clearances for Abbott, cybersecurity vulnerabilities for Baxter Welch Allyn, clearance of an AI solution from Heuron to alert of impending intracranial hemorrhage and clearance of an easy-to-use EEG system from Zeto. Read More