Scientific Wave Pushes CBER Into Brighter Light
Executive Summary
What are US regulators doing to prepare for adequate review of the upcoming wave of gene therapy applications, and what other actions could CBER take to ensure it is able to facilitate the expected onslaught of breakthroughs in this field? Consultant Nancy Bradish Myers weighs in.
You may also be interested in...
COVID-19’s Damage To Gene Therapy Development May Last Years
US FDA's Peter Marks says the field is robust, but hedges on approval predictions for the coming years because of pandemic’s effect.
CBER Will Staff Up With 100 More Reviewers ‘By Hook Or By Crook,’ Marks Says
US biologics center is getting back to regular business now that COVID-19 work is subsiding; director Marks credits acting commissioner Woodcock with using all available mechanisms to staff up.
CBER Proposes Increasing Cell, Gene Therapy Staff In PDUFA VII
'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.