Senate Appropriators Worry About US FDA Gene Therapy, Complex Generic Approval Pace
In report language, the committee funds more CBER cell and gene therapy staff for rare diseases and suggests AI be considered to speed up complex generic assessments.
You may also be interested in...
HHS Inspector General’s timeline means Congress won’t have findings to use during upcoming user fee renewal debate; ‘review’ is not an ‘investigation’ which could come with potentially more damning legal consequences for the agency.
Woodcock again defends the decision, saying Congress intended accelerated approval for those situations.
Report language includes several mentions of improving trial diversity and recruitment, while bill offers a 5% increase in funding.