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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
On Tuesday, the FDA’s Medical Imaging Drug Advisory Committee (MIDAC) green lighted Lumicell’s device-injection combo product aimed at helping surgeons detect residual breast cancer in breast tissue after lumpectomies. Read More
AI models developed by GE HealthCare used readily available clinical data to forecast cancer immunotherapy outcomes and adverse reactions with 70-80 percent accuracy, according to an article published in the Journal of Clinical Oncology Clinical Cancer Informatics. Read More
The FDA met its March 5 deadline to provide Vanda Pharmaceuticals with the details of its decision to deny the company’s request for a hearing on an sNDA for a jet lag disorder treatment, finding “that there is no genuine and substantial issue of fact justifying a hearing.” Read More
President Biden announced on Monday that manufacturers for all ten drugs have agreed to participate in the Inflation Reduction Act (IRA) drug price negotiations — but that negotiations continue as all drugmakers have submitted counter offers. 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
During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More