4yr
Come On In, The Water’s Fine: FDA Should Fully Embrace Remote Inspections
Source : Medtech Insight
The COVID-19 pandemic produced a near endless list of challenges for the US Food and Drug Administration, including how to handle medical device facility inspections. As the pandemic showed, the...
4yr
Fast-Track Loss In EU For Celgene’s CAR-T Cell Therapy
Source : 'The Pink Sheet'
The review of liso-cel, Celgene/Bristol Myers Squibb's potential new CAR T-cell therapy for R/R DLBCL, is facing regulatory setbacks in the EU as well as in the US.
Celgene’s investigational CAR...