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…
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…
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…
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…
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…
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 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…
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…
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…
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…