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With the release of a strategic action plan during the National Health Information Infrastructure conference last month, HHS advanced the Bush administration’s efforts to increase the use of information technology (IT) in the nation’s healthcare system.
A widely anticipated FDA workshop on the scientific issues surrounding generic biologics will be held before the end of the year, an agency source confirmed yesterday.
The FDA has announced name and address changes for a pair of divisions within the Center for Drug Evaluation and Research’s (CDER’s) Office of Compliance.
An FDA scientist’s controversial conclusion that a link exists between antidepressant use and suicide in pediatric patients appears to have been vindicated, according to the former director of the National Institute of Mental Health.
Three of Ranbaxy Laboratories’ generic fixed-dose combination (FDC) AIDS drugs have been removed from the World Health Organization’s (WHO’s) list of recommended medicines based on concerns the products may not be bioequivalent to their brand counterparts.
The FDA has approved the first brand once-daily fixed-dose combination (FDC) AIDS drugs, while generic firm Ranbaxy has said it plans to seek FDA approval for its own FDC generic products aimed at AIDS patients in developing countries.
One year after the FDA implemented sweeping new patent rules to better balance the competition between brand and generic drugmakers, generic firms say brand firms are threatening the industry with a new tactic: cutting deals with generic firms to market authorized generic products.
The city of Boston has become the latest municipality encouraging the importation of prescription drugs to receive a warning from the FDA about the dangers such programs create for consumers.
PhRMA is urging the FDA to withdraw or scale back its Part 11 regulation in favor of other more recently approved legislation addressing electronic records, arguing that the rule is too prescriptive and the cost of compliance too high.