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Drug sponsors should break down nonalcoholic fatty liver disease into three stages and focus on the most dangerous, the FDA suggests in new draft guidance issued Monday. Read More
A federal lawsuit filed in Massachusetts claims Indian generic drugmaker Hetero and its U.S. subsidiary Camber Pharmaceuticals ignored warning signs that the blood-pressure drug valsartan was contaminated and continued to supply it in the United States. Read More
The FDA denied a petition from several pharmaceutical and outsourcing facilities urging the agency to keep implantable testosterone pellets off its Difficult to Compound list — but noted that so far it hasn’t made any moves to include it. Read More
Generic drugmakers urged the FDA to allow for more flexibility in draft guidance on product identifiers under the Drug Supply Chain Security Act (DSCSA). Read More
“Recent reports analyzing increasing insulin prices have noted a growing difference between a product's average list price and the net price that is ultimately received by the manufacturer,” Collins and Shaheen said. Read More
The FDA granted orphan status to 26 drugs whose applications didn’t include all required information, , according to a Government Accountability Office report released on Friday. Read More
As part of its efforts to contain the opioid epidemic, the U.S. Attorney for the District of Massachusetts issued warnings to opioid prescribers whose patients died of overdoses. Read More
Sen. Jeff Merkley (D-Ore.) introduced the Low Prices Drug Act (S.3680) — a bill that would tie drug prices to drugmakers’ access to Medicare and Medicaid patients and align U.S. drug prices with those in other developed countries. Read More