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Pfizer subsidiary Meridian Medical Technologies is under continued pressure from the FDA to improve oversight and quality at its Missouri plants. 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
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
Congressional negotiators are working to hammer out a new federal budget proposal for fiscal 2014 and fiscal 2015, and a group of lawmakers hopes to use the budget deal to shield FDA user fee revenue from any across-the-board sequestration cuts. Read More
Just days after the FDA’s new authorities over compounding pharmacies were signed into law, the agency last week issued draft guidances detailing how facilities register and report product information to the FDA. Read More
Eli Lilly’s plans for strong sales growth in 2014 have been set back, with the drugmaker saying Thursday its promising depression treatment edivoxetine has failed in late-stage testing. Read More
Drugmakers are pushing back against Australian draft guidance on batch release protocols, asking the Therapeutic Goods Administration (TGA) to allow authorized persons to release batches without access to the product’s complete marketing application. 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