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The FDA warned manufacturers of ranitidine products not to use a high-temperature test for N-Nitrosodimethylamine (NDMA) because it actually generates high levels of the impurity. Read More
The FDA issued a warning letter to Lupin Pharmaceuticals over repeated failures at its Mandideep site near Bhopal in central India, including inadequate out-of-specification investigations. Read More
Johnson and Johnson announced a $20.4 million settlement with two Ohio Counties for its alleged role in the opioid crisis, as other defendants, including major retailers, remain on the hook for a bellwether trial scheduled to start on Oct. 21. Read More
Reports that the Trump administration will nominate MD Anderson Cancer Center oncologist Stephen Hahn to lead the FDA went unconfirmed by the White House on Wednesday. Read More
The complaint alleges that Momenta and Sandoz agreed to share the profits of Sandoz’s generic enoxaparin so long as they remained the sole source of the generic drug in the U.S. Read More
The agency suggests decentralizing trials and broadening inclusion criteria to include as many different types of subjects as possible in trials. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Kowa Pharmaceuticals for a video that makes false and misleading claims for its high cholesterol drug Livalo (pitavastatin). Read More