CBER Designing Triage System For Gene Therapy Submissions In Lieu Of ‘First In, First Out’ System
Ideally, the system will prevent some cell and gene therapy programs from slowing, CBER Director Peter Marks says.
You may also be interested in...
Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.
The agency reissued the user fee notice, saying fewer dollars were needed for new staff.
Bubble was short-lived, but still could create workload problems for the US FDA as it navigates the end of the coronavirus pandemic.