Whether Vertex Pharmaceuticals’ off-target safety analysis of its investigational sickle cell gene therapy exagamglogene autotemcel (exa-cel) is sufficient or not is the issue before an FDA advisory committee on Tuesday…
In a move with ramifications for medical devicemakers, the Biden administration issued an executive order Monday targeting powerful AI systems, requiring developers to share safety test results and other critical…
Virtual listening-only sessions for the public regarding the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program began Monday — and will continue through mid-November — providing an opportunity for…
With the quality metrics movement resurfacing and CDER’s quality maturity model publication in the news, lately I have been giving much thought to what quality culture means and how to…
As the first session of the 118th Congress continues, FDAnews will track important pending legislation that has been acted on since July 1, to keep you updated on laws and…
The election of newly installed Speaker of the House Mike Johnson (R-La.) means the impending government shutdown on Nov. 17 almost certainly won’t occur, says Steven Grossman, executive director of…
An upstream occlusion alarm in certain of B. Braun’s infusion pumps that may sound when no occlusion exists and cause the pump to stop pumping caused the company to issue…
In a win for Masimo, the U.S. International Trade Commission (ITC) banned the importation of Apple watches with light-based oximetry technology that monitors heart rate and blood oxygen because the…
Over the past week, the FDA issued draft guidance on communications of off label uses of approved/cleared medical products and remote inspections of drug manufacturing and BIMO facilities. Source: Drug…
A new publicly searchable database contains detailed information on all 141 Alzheimer’s disease (AD)-targeting drugs involved in 187 active clinical trials in the U.S. and around the world. Source: Drug…