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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The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing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
When it comes to integrating artificial intelligence into healthcare networks, stakeholder enthusiasm appears to be outstripping FDA oversight, according to a survey by the Berkeley Research Group. Read More
Bankrupt Endo Health Solutions (EHSI) has agreed to plead guilty and pay just over $2 billion to resolve criminal and civil investigations, as well as its bankruptcy debt, related to the company’s sales and marketing of the opioid drug Opana ER (oxymorphone), the Department of Justice (DOJ) announced. Read More
None of the nine pharmacy benefit managers (PBM) ordered in 2022 and 2023 to turn over business practice documents to the FTC have fully complied, FTC Chair Lina M. Khan told a bipartisan group of legislators who wrote in January seeking an update on the inquiry. Read More