FDA May Ease Up On CV Safety Requirements For GI Motility Drugs Compared To Diabetes, Obesity
Executive Summary
Developers of 5-HT4 agonists should not be required to conduct dedicated cardiovascular studies, despite the safety concerns raised by two previously approved products in the class, an FDA advisory committee said.
You may also be interested in...
Shire’s Prucalopride Brings Real-World CV Safety Data To US FDA Panel, But Will It Be Enough?
European postmarketing epidemiological study results ‘reasonably exclude’ a greater than three-fold increased risk of major adverse cardiovascular events with the constipation drug but, due to potential bias, cannot definitively exclude a possibly unacceptable level of risk, agency says.
Keeping Track: FDA Approves Novel HIV Treatment, New Dosing Regimen For Opdivo; Another Rare Pediatric Disease Designation For Prometic
The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA Commissioner Califf Takes On Misinformation, Starting With ‘Rumor Control’
Agency leader expects to spend about a year developing a strategy to combat misinformation. On 5 August, the agency unveiled what appears to be an early component of the initiative – a web page titled Rumor Control, with facts about the safety and components of COVID-19 vaccines.