Robert Califf’s Chance To Make History At The US FDA
Executive Summary
Robert Califf’s first tenure as US FDA Commissioner was decidedly anti-climactic. His return trip – assuming the Senate confirms him – will be potentially transformational: he will be the leader that defines what FDA is after COVID.
You may also be interested in...
Resiliency Roadmap Update: US FDA Exceeds FY 2021 Inspection Projections
While better than one its ‘best case’ scenarios, FDA has completed just 31% of 15,514 domestic surveillance inspections planned for FY 2021, applications are still being delayed, and foreign inspections have for the most part yet to be tackled.
Robert Califf Likely To Find Many Familiar Problems Upon His Return To US FDA
President Biden’s pick for FDA commissioner should remember many of the hot-button issues that he would face upon confirmation, such as drug pricing and approval standards.
In Search Of A Stimulant Use Disorder Treatment: ‘We’ve Been Doing It Wrong’
US FDA official questions whether problem is due to population selection, outcome measures, or study duration. Potential endpoints include change in disease status as measured by DSM-5 criteria, cognitive function and quality of life, experts say.