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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
The DOJ said the criminal resolution includes the second-largest set of criminal financial penalties ever levied against a pharmaceutical company. Read More
In a likely boost to Joe Biden’s affection for Delaware, a federal judge in U.S. District Court there Friday handed a victory to the President’s much-challenged Inflation Reduction Act (IRA), in another setback for big pharma in challenging the Medicare Part D drug pricing program. Read More
The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand. Read More