CDRH standards and regs director
This article was originally published in The Gray Sheet
Executive Summary
George Brubaker, deputy director of the device center's Office of Standards and Regulation, is named acting director of the office, replacing Phil White, who retired July 2
You may also be interested in...
Post-Brexit UK Risks Being ‘Left Out In The Cold’ As EU Coordinates Action On Shortages
The UK is not alone in experiencing drug shortages, as data from across Europe show, but its departure from the EU makes it more difficult to respond to supply chain pressures, according to new research.
Dr Reddy’s Knocked Back On Rituximab In US
Dr Reddy’s has received a complete response letter from the US FDA, knocking back its proposed rituximab biosimilar rival to Rituxan.
Sandoz And Samsung Celebrate Stelara Rival’s EU Approval
Sandoz and Samsung Bioepis have received final European Commission approval for their partnered Pyzchiva biosimilar rival to Stelara. But with European competition on ustekinumab due to kick off in just a matter of months, further applicants are also waiting in the wings.