FDA worries over personnel shortfall as review times suffer
This article was originally published in Clinica
The US FDA is experiencing a serious brain drain that is already beginning to contribute to rising review times. The Office of Device Evaluation (ODE) alone has lost 31 staff in the last year many, coming within the pivotal divisions of Cardiovascular and Respiratory Devices.
You may also be interested in...
The US Food and Drug Administration posted two device-related closeout letters in November.
Jazz and PharmaMar need to see what further data will be needed to convert their FDA authorization into a full approval following disappointing results in the ATLANTIS Phase III trial.
As arguments rage over whether the UK regulator has rushed its assessment of the Pfizer/BioNTech vaccine, the European Medicines Agency explains why its conditional marketing authorization approach is taking a little longer.