US FDA Kills ISO Voluntary Audit Program As MDSAP Efforts Accelerate
This article was originally published in Clinica
The US FDA has terminated its three-year-old ISO 13485 voluntary audit program, which gave medtech companies the chance for a one-year reprieve from an FDA inspection, to put all attention on the global Medical Device Single Audit Program.
You may also be interested in...
Butterfly Network chose SPAC route with Longview Acquisition Corp. to scale its business and expand into the home market in 2021.
Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.
With Warp Speed Decisions Already Made, Transitioning To Biden Admin Should Be No Trouble, Slaoui Says
As vaccines near availability, Moncef Slaoui says his full-time role at OWS may be ending. He has not met with the Biden Transition team, but notes that other Warp Speed officials have.