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.

Democrats on the committee say the funding level will cause the FDA to have to cut its core programs to fund pay raises.

The letter also advises the company to “comprehensively review your website, product labels, and other labeling.

According to the FDA, the selected START participants will be able to obtain frequent advice and regular ad-hoc communication with agency staff.

Lingo will track glucose and provide personalized insights and customized coaching to help people create healthy habits.

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 ...

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FDAnews The trusted source for drug and device insights Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments. For decades, ...

Eli Lilly will make a case for its antiamyloid antibody donanemab on June 10, trying to reassure the Peripheral and Central Nervous System Advisory Committee that the drug is safe, despite the serious ...

A Chinese drugmaker was storing sterile injectable drugs bound for the US market on corroded metal racks which themselves stood in pools of water dripping from black mold-covered condensation pipes, ...

DexCom’s G7 prescription continuous glucose monitoring (CGM) system now connects directly to Apple Watch for users in the US, making it the first to offer real-time glucose readings so that users can ...