FDA’s Hahn Says The Agency Is Meeting Its MDUFA Review Goals – For Now
US FDA commissioner Stephen Hahn says in a 16 April communique that the agency is still performing “user-fee review activities” despite the ongoing coronavirus pandemic – but he warns that the FDA might not be able to do so “indefinitely.”
You may also be interested in...
In a 23 June blog post, FDA head Stephen Hahn issued a statement praising agency staff for continuing to meet their statutory obligations under MDUFA V considering the added difficulties of working through the coronavirus pandemic. While noting the agency is being creative in how it works in its new COVID-19 reality, he cautioned the FDA may not be able to meet those deadlines in the future if things continue as they are. Hahn also in his blog post addressed in-person inspections of manufacturing facilities.
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?
People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.