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The Congressional Budget Office (CBO) estimates bipartisan legislation designed to speed generic drugs to market could save the federal government as much as $3.3 billion. Read More
FDA guidance on submitting field alert reports contradicts federal regulations on the time frame for when reports must be submitted, Perrigo and GlaxoSmithKline said in public comments. Read More
The EMA expanded its investigation of valsartan impurities after a new contaminant was discovered in an Indian manufacturer’s active substance, losartan. Read More
“I believe it’s something that’s going to have wide support,” said temporary voting member Paul J. Smith, director of the University of Maryland’s statistics program. Read More
“The inferences plaintiffs draw — namely, that Allergan's efforts bore fruit in causing delay — are logical and amply support the plausibility requirement,” the judge said. Read More
Claims that Allergan repeatedly tried to delay Restasis generics from entering the U.S. market are plausible, a U.S. District Judge ruled on Tuesday, shooting down the pharmaceutical giant’s attempts to have the multi-district litigation dismissed. Read More
An FDA advisory panel voted unanimously Thursday to recommend that the agency establish patient-focused dissolution standards for extended-release solid oral dosage forms. Read More