We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Generics firm Par Pharmaceuticals has agreed to pay Salix Pharmaceuticals $100 million to settle a patent infringement lawsuit over its version of Salix’s heartburn drug Zegerid. Read More
Drugmakers say they will be forced to abandon social media due to proposed FDA requirements to present both risk and benefit information in character-limited social media messages — a requirement they contend the agency doesn’t even follow. Read More
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