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The FDA stands by its allegation that Novartis abused the citizen petition process to stall approval of generic versions of Reclast, and the agency has rejected a company request that it retract its statements from the public record. Read More
Prosecutors appear ready to lean more heavily on the False Claims Act in prosecuting off-label marketing cases, sidestepping a ruling in the U.S. Second Circuit that found off-label promotion was protected free speech and not prosecutable under the 1938 FD&C Act. 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
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