As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws…

The FDA has called out three drugmakers for lack of compliance with current good manufacturing practices (cGMP) and marketing unapproved products, among other lapses. Source: Drug Industry Daily

AdvaMed commended CMS for its July 10 proposed rule that includes separate payments for diagnostic radiopharmaceuticals are used to diagnose and treat diseases such as Alzheimer’s and cancer. Source: Drug…

A Texas pharmaceutical marketer was sentenced to two years and five months in federal prison and ordered to pay over $59 million in restitution for conspiring to defraud the US,…

This week, the FDA published a final guidance on clinical considerations for studies of opioid use devices. Draft guidances were issued for misinformation about drugs and devices, use-related risk analyses…

Hamilton Medical has issued a recall for correction of the software in one of its ventilators, an issue that could cause the device to fail during procedures, a recall which…

The FDA offers new recommendations for testing and information to include in 510(k) submissions for dental resin devices and the ultraviolet curing lights used to set the resins, in two…

The FDA issued a complete response letter (CRL) to Novo Nordisk for insulin icodec — a once-weekly long-acting human insulin analogue — raising questions about the manufacturing process and the…

The FDA has finalized its guidance on crafting phase 3 clinical trials for devices designed to treat opioid use disorder (OUD), providing sponsors with direction on defining patient populations, recording…

Health care providers and facilities are being warned by the FDA to stop using Medtronic NIM (neural integrity monitor) Contact EMG (electromyogram) reinforced endotracheal tubes and NIM Standard EMG reinforced…