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Late Monday afternoon, the FDA announced its $7.2 billion budget request as part of President Biden’s $7.3 trillion fiscal 2025 proposed budget, which was released Monday. Read More
Manufacturers of cyber devices must have a plan to keep those devices secure for the product’s entire lifecycle, and sponsors of nonprescription drugs can include some minor labeling changes on an annual report, according to two new draft guidances issued by the FDA. Read More
Drugs for cognitively and functionally normal people who have the pathophysiologic changes of Alzheimer’s disease (AD) could be approved on a single biomarker outcome, according to the FDA’s new draft guidance on drug development for early AD. Read More
Manufacturing and distributing adulterated drugs for nearly a decade — some of which originated in a foreign country without FDA authorization — has brought $3.5 million in penalties to a Pennsylvania generic pharmaceutical company. Read More
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). Read More
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. Read More
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. Read More
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 early next year. Read More
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. Read More
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 Robert Califf. Read More