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FDA officials sought to clear up questions about what standards the agency will apply when approving biosimilars, emphasizing that manufacturers must prove their products are “highly similar” to the reference product in order to win a green light. Read More
The FDA slammed Cipher Pharmaceuticals for an email that contains overblown superiority claims promoting a cholesterol drug, the latest signal this year that the agency is scrutinizing drugmakers’ electronic promotions. Read More
As the reorganization of the FDA inspectorate takes shape behind the scenes, details are emerging about how the agency will operate under its new structure — including plans to rely exclusively on specialized teams to carry out all facility inspections. Read More
While European regulators approve new drugs at a faster clip than their Canadian counterparts, both jurisdictions pull drugs from the market for safety reasons at the same rate, a new study finds. Read More
The FDA should speed up its ANDA median approval times so that generics manufacturers with first-filer status don’t lose their 180 days of marketing exclusivity, firms said. Read More
Marcus Research Laboratory was handed a Form 483 for not performing stability testing or properly monitoring the production process for the active pharmaceutical ingredient iodine. Read More
Amgen is recalling nine lots of its anemia drug Aranesp after a small number of syringes were found to potentially contain cellulose and/or polyester particles. Read More
The National Institutes of Health is asking pharmaceutical manufacturers, wholesalers and repackagers to submit samples of their pills as part of an ongoing push to better identify drug products. Read More
Two FDA advisory panels last week overwhelmingly recommended the agency not approve Clarus Therapeutics’ Rextoro testosterone replacement therapy. Read More
House lawmakers are making a new push to pass stalled legislation that would enable the FDA to accept less clinical data to approve antibiotics, the latest effort from the federal government to combat the spread of drug-resistant infections. Read More