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.
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
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
British regulators have revised their recommendations on the reporting of pediatric adverse drug reactions to focus on severe or serious events, a change that addressed complaints that the previous system was overly burdensome. Read More
The FDA has withdrawn three holdout ANDAs for products containing the narcotic propoxyphene due to safety issues, but the drugs have likely long since been discontinued, the agency said. 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
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
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 UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is leading a three-year initiative that seeks to harness the power of social media to report adverse drug events. Read More
The FDA has withdrawn three holdout ANDAs for products containing the narcotic propoxyphene due to safety issues, but the drugs have likely long since been discontinued, the agency said. Read More
Draft FDA guidance on how drugmakers can use social media and web-based forums threatens to prevent the industry from interacting with customers online for fear that companies will be responsible for continuously monitoring any discussions they participate in, drugmakers say. Read More
Beleaguered Indian generics maker Wockhardt has initiated a voluntary Class II recall of 11,661 bottles of metoprolol succinate, a generic version of AstraZeneca’s blood pressure drug Toprol-XL. Read More