FDA's Biosimilars Meeting Management Should Improve After Reorg In New Drug Office
Executive Summary
US FDA met more biosimilar user fee program meeting performance goals in FY 2018 compared to prior year but still fell short in scheduling for three of five types of meetings. Office of New Drugs reorganization, once completed, should address some logistical scheduling issues.
You may also be interested in...
Califf: Industry Should Be Reminded Of US FDA’s Separate Development Advice, Application Assessment Roles
Experts wonder why the FDA Commissioner commented on a system seemingly working fine, but Califf says it is necessary to remember the potential conflict between the two roles.
BsUFA III Meeting Improvements To Cut Requests, Improve Biosimilar Development Efficiency
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.
BsUFA III Meeting Improvements To Cut Requests, Improve Biosimilar Development Efficiency
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.