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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changes of Alzheimer’s disease (AD) could be approved on a single biomarker outcome, according to the FDA’s new draft guidance on drug development for early AD.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
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 revisions to a guidance on residual solvents for analytical methods. Read More
The ongoing efforts by the White House to make major dents in drug pricing brought heated criticism from Senate Republicans this week with President Joe Biden’s reported interest in seizing taxpayer-funded drug patents through unused, decades-old legislation. Read More
The FTC, Department of Justice (DOJ) and HHS have jointly launched a cross-government public inquiry into private-equity and other corporations’ increasing control over healthcare, further signaling the Biden administration’s commitment to lowering healthcare costs. Read More