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CMS allows Medicare Part D to cover “terminated” drugs that have run out their shelf lives or been withdrawn from the market, says HHS’s Office of Inspector General. Read More
The complaint accused Rite Aid of maintaining an “undisclosed, dual pricing scheme” for generics available through its discount generic drug program. Read More
When a risk can’t be excluded on the basis of negligible exposure, sponsors can get information from toxicological databases, or by using toxicological techniques. Read More
The EMA’s Committee for Medicinal Products for Human Use released draft guideline on environmental risk assessments for human drugs — including decision trees to help sponsors decide if they need a Phase I, Phase II or customized risk assessment. Read More
The FDA Monday finalized its guidance on post-complete response letter meetings with ANDA applicants, spelling out the criteria for granting or denying meeting requests. Read More
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break down nonalcoholic fatty liver disease into three stages and focus on the most dangerous, the FDA suggests in new draft guidance issued Monday.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Generic drugmakers urged the FDA to allow for more flexibility in draft guidance on product identifiers under the Drug Supply Chain Security Act (DSCSA).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