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The FDA issued a warning letter to Fresenius Kabi for GMP violations observed at its manufacturing facility in Himachal Pradesh, India, citing a failure to investigate sterility issues. Read More
Amid controversy over the high cost of its newly approved gene therapy Luxturna — $850,000 before discounts — Spark Therapeutics announced a series of initiatives to improve patient access to the drug, including outcomes-based arrangements with Harvard Pilgrim and Express Scripts. Read More
The Justice Department recovered more than $900 million from medical product manufacturers relating to False Claims Act violations in fiscal 2017, down from $1.2 billion in 2016. Read More
In a move aimed at speeding reviews of generics this year, the FDA released a new draft guidance on ANDAs for public comment along with an updated Manual of Policies and Procedures (MAPP) for agency staff that went into immediate effect. Read More