BsUFA III Expands Biosimilar Supplement Review Goals To Speed Approvals
Six supplement categories based on submission content will be created with review goals between three and 10 months.
You may also be interested in...
Through three-quarters of fiscal year 2023, CBER had hired nearly 70% of the mandated new PDUFA VII employees, while CDER had only hired 40%. The drug center also hired only 36% of the required new BsUFA III employees.
CBER Director Peter Marks said the FDA’s remote and in-person work system is functioning well and continues to help recruitment.
The FDA has overruled the results from its own formula intended to match resource levels with workload every time except once.