Real-time communication between sponsors and regulators is a top priority for Nicole Verdun, the recently installed Super Office director for the Office of Therapeutic Products (OTP). Source: Drug Industry Daily
The Senate passed a fiscal 2024 funding package late Friday that includes a total of $6.72 billion for the FDA, which was signed by President Biden on Saturday. Source: Drug…
President Biden wants to extend the cost-capping Inflation Reduction Act (IRA) far beyond Medicare recipients and their prescriptions, and allow Medicare to negotiate the prices of 500 drugs over the…
Rather than handing out the approval Lilly was hoping for, the FDA will put donanemab, the company’s antiamyloid contender, through its paces in an upcoming advisory committee meeting. Source: Drug…
The European Commission (EC) has released a draft regulation spelling out how member states should implement the pending EU law on health technology assessment (HTA), due to go into effect…
Medtronic Neurosurgery’s recall of its Duet External Drainage and Monitoring System (EDMS) catheter tubing due to a potential for the catheter disconnection from the patient line stopcock connectors has been…
Over the past week, the FDA endorsed International Council for Harmonisation (ICH) recommendations, in final guidances covering analytical procedure development and validation of such procedures. Source: Drug Industry Daily
Due to an overfill feature in mixing medical ingredients potentially leading to an “over-delivery” and adverse health consequences, Baxter Healthcare has recalled for product correction its ExactaMix Pro 1200 and…
At its best, AI could “radically change” clinical practice and patient outcomes, and realign the country’s medical reimbursement system to reward excellence in both those areas, according to FDA Commissioner…
The FDA has endorsed International Council for Harmonisation (ICH) recommendations, publishing this week final guidances covering analytical procedure development and validation of such procedures, while the ICH itself has announced…