BsUFA III Meeting Improvements To Cut Requests, Improve Biosimilar Development Efficiency
Executive Summary
New biosimilar Type 2a meeting will facilitate faster development, stakeholders said, but one representative also warned that the inspection backlog must be eliminated in order for the US FDA to meet the new user fee program commitments.
You may also be interested in...
Remote Methods Drove Most US FDA Enforcement Actions In FY 2021
Product sampling and remote records requests accounted for most import alerts and drug GMP warning letters over the past year – and may play key role post-pandemic.
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.
US FDA's On-Time Review Decision Rates Slip During The Pandemic, Especially For Biosimilars
Likelihood of an on-time decision on a biosimilar application dropped significantly during the first nine months of the pandemic and declined a bit for new and generic drug applications. FDA says BsUFA review performance is function of program's small sample size.