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The Generic Drug User Fee Amendments of 2012 do not allow for a waiver, reduction or postponement of finished dosage form (FDF) facility fees for small and/or foreign businesses, the FDA says in a letter denying a citizen petition submitted by Square Pharmaceuticals. Read More
Following setbacks to its hepatitis C drug program, Idenix Pharmaceuticals is appealing to the courts to keep Gilead’s competing hepatitis C treatment off pharmacy shelves. Read More
The FDA wants Wockhardt to investigate whether management was involved in quality data manipulation at its Chikalthana, India, facility before the agency will lift an import ban it slapped on the plant Nov. 26. Read More
With the new pharmaceutical track-and-trace law’s deadline for lot-level pedigrees looming, the FDA is still unclear about how it will regulate the complex requirement. Read More
The FDA plans to launch a study examining how consumers view risk information in direct-to-consumer (DTC) prescription drug advertisements, the latest study delving into how drugmakers craft ads. Read More
The FDA’s unusual demand that an importer of active pharmaceutical ingredients (API) list the distributors that might sell finished product created with the API has sparked a lawsuit that could further complicate U.S. border control processes. Read More
After years of pressure from lawmakers and drugmakers, the Obama administration appears to be surrendering its push for a reduced seven-year exclusivity period for biologic drugs. Read More
Admitting generic drug users are caught in a catch-22, a federal appeals court has dismissed liability suits brought by patients that took the generic version of Reglan (metoclopramide). Read More
While developers of next-generation heart drugs known as PCSK9 inhibitors will need to present data showing their effectiveness at lowering cholesterol, blood pressure and inflammation, they will not be required to show reduced heart attack or stroke, according to the FDA. Read More
New technology and anxiety over expiring patents have driven pharma to triple clinical development of large molecule and biologic drugs over the past decade, says an industry expert. Read More