US FDA Drug Review Hiring Doing Well Despite Pandemic
Executive Summary
CDER has ‘turned the corner’ on hiring during 2020, acting Director tells stakeholders – though the added workload from COVID-19 makes that hard to see.
You may also be interested in...
CDER Hiring Is Booming: Flexibility Of Remote Work During Pandemic Helps Drive Numbers, Cavazzoni Says
Employment totals have also been aided by a (surprisingly) low attrition rate during the pandemic and CDER’s full use the ‘Cures’ authorities; 20% of CDER’s workforce has been hired under Cures.
Is The US FDA At A Tipping Point?
Wall Street is worried that a cluster of recent negative regulatory events means tougher reviews going forward. That concern is probably overdone, but a year into the COVID pandemic is a good time to take stock of how FDA is doing.
BsUFA III: Reauthorization Process Begins With US FDA Considering Staffing, Uptake Issues
Biosimilar availability may not be in the its purview, but the FDA still is thinking about ways to help industry deal with the issue and support sector growth.