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Drug sponsors applying to include products on the Australian registry should submit both favorable and unfavorable information with their nonclinical study reports, according to amended guidance. Read More
The FDA said it plans to create a central database with information on how different parties experience risk evaluation and management strategies, a project that is part of the agency’s effort to improve communications around REMS requirements and activities. Read More
A European biotech association is calling on EU regulators to develop new guidance on the labeling of biosimilars that will end the practice of assigning a generic label to the complex products. Read More
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
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
The FDA is moving to ease industry fears that ANDAs filed after September of this year will receive priority over earlier applications simply because they were filed before the law required the agency to assign review deadlines to new applications. Read More