A new FDA guidance set to take effect immediately extends the agency’s COVID-era policies requiring supplementary submissions for certain modifications to a device approved under the premarket approval (PMA) or…
Nostrum Laboratories and its CEO have struck a potential $50 million settlement with the Department of Justice (DOJ) to resolve allegations the company knowingly underpaid Medicaid rebates for its Nitrofurantoin…
In this edition of Quick Notes, we cover medical device clearances for GE HealthCare’s Allia IGS Pulse for cardiac imaging, Ventric Health’s Vivio system for heart failure diagnosis, the Ori…
In an agreement worth up to $600 million, Eli Lilly will acquire Beam Therapeutics’ opt-in rights to three of Verve Therapeutics’ cardiovascular disease gene-editing programs in exchange for cash, potential…
Seeking to address the growing problem of how misinformation undermines confidence in both science and the FDA, the Regan-Udall Foundation recently released a report focusing on how the FDA can…
Although Medicare will now cover antiamyloid antibodies fully approved for early Alzheimer’s and the PET imaging required to qualify for them, questions remain about how coverage will shake out for…
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…