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 head of communications Virginia Cox is leaving the agency in January to pursue other opportunities. Read More

After extensive discussions with the FDA, MiMedx has agreed to settle complaints of selling unlicensed products. 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

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

Following setbacks to its hepatitis C drug program, Idenix Pharmaceuticals has turned to the courts to try to delay Gilead’s competitor hepatitis C treatment, claiming the drug infringes several Idenix-owned patents. Read More

The FDA is demanding Wockhardt investigate whether management was involved in quality data manipulation at its Chikalthana, India, facility before the agency will lift the import ban it has slapped on the plant. Read More

Twenty-five drugmakers, including generic drugmakers Ranbaxy and Perrigo, have agreed to pay the state of Louisiana more than $88 million to settle Medicaid and Medicare fraud charges lodged against them as part of the state’s continuing crusade to recover funds paid out to drug companies improperly. Read More