New law in France for cell and genetic therapies:
This article was originally published in Clinica
New rules have been introduced in France governing clinical trials of cells, cell therapies and genetic therapies. A decree published in the Journal officiel of April 9 demands detailed information concerning the quality of the sourced and finished materials and the microbiological safety review. It also calls for an analysis of the potential risks of the materials (toxicity, carcinogenicity etc) and for detailed information concerning the clinical trial protocol.
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.