FDA May Ease Up On CV Safety Requirements For GI Motility Drugs Compared To Diabetes, Obesity
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.
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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.
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.