FDA To Ask Advisory Committees To Review Phase IV Safety Trial Designs
FDA is preparing to take proposals for large post marketing studies to its drug advisory committees to solicit outside advice and counsel on the design and term of the new mandatory studies
You may also be interested in...
The IL-1 receptor has long been a target for autoimmune therapies. Now, data are emerging using several drugs, notably IL-1 beta antibodies, which support the general notion that blocking the IL-1 pathway could be useful in treating diabetes, particularly in patients at risk of cardiovascular disease. Indeed, one recent paper suggests that it could even be a therapeutic strategy to prevent heart failure after acute AMI.
FDA is using its new Risk Evaluation and Mitigation Strategy authorities much more frequently in the second year since the law took effect
Political pressure from FDA outsiders interested in improving drug safety oversight may have backfired, resulting in an embarrassing advisory committee meeting for the agency. The July 30 review of a cardiovascular safety signal for GlaxoSmithKline's diabetes drug Avandia became a forum to play out another controversy between the Office of New Drugs and the Office of Surveillance and Epidemiology