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Thousands of laboratory results at Sun Pharma’s Karkhadi manufacturing plant were improperly deleted, according to an FDA warning letter that blasts the Indian generics firm for failing to ensure that tests conducted at the facility included complete data. Read More
House lawmakers advanced an FDA funding package that directs the agency to address a multitude of controversial issues, including justifying the costs to generic drugmakers of the agency’s proposed labeling overhaul. Read More
Generic drug giant Teva received FDA clearance May 30 to market exclusive versions of Pfizer’s blockbuster arthritis pain drug Celebrex (celecoxib) in the 100 mg, 200 mg and 400 mg capsule forms. Read More
Generic firm Mylan said Monday that it had reached a settlement with Pfizer to market versions of Celebrex (celecoxib), marking the latest twist in the generic conversion of the blockbuster arthritis pain drug. Read More
Eli Lilly said it will begin sharing clinical trial data used in support of regulatory filings in the U.S. and Europe with qualified researchers, becoming the latest drugmaker to join the growing clinical trial data transparency movement. Read More
The FDA is trying to encourage mobile app and web developers to give wide distribution to drug adverse events data by providing the data in an easy-to-use electronic format. Read More
Delaware has become the latest state to let pharmacists substitute biosimilar products for the prescribed biological reference product, a move cheered by a national trade group representing biopharmaceutical manufacturers. Read More
The FDA has warned two more compounding pharmacies for actions that occurred prior to passage of a new federal law that boosted the agency’s authority over such facilities. Read More
The FDA has issued a warning letter to Mexican biologics maker Instituto Bioclon for significant GMP deviations including failures to ensure adequate environmental monitoring and employee training. Read More
Massachusetts-based Fresenius Medical Care North America has issued two voluntary recalls of a concentrate used in dialysis machines over fears of bacterial contamination, the FDA said. Read More