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The FDA is “making the process for copying these medicines more efficient and creating an easier path for generic alternatives to enter the market,” said Commissioner Scott Gottlieb. Read More
The discovery process for a revived whistleblower suit against Gilead would be more trouble than it’s worth, the Justice Department said in a brief to the Supreme Court last week. Read More
The FDA granted a petition to add warning labels for hypnotic drugs on the risk of injury from falling, but shot down calls for tougher risk assessments by drug sponsors. Read More
CMS allows Medicare Part D to cover “terminated” drugs that have run out their shelf lives or been withdrawn from the market, says HHS’s Office of Inspector General.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break down nonalcoholic fatty liver disease into three stages and focus on the most dangerous, the FDA suggests in new draft guidance issued Monday.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