US FDA's Generic Research Projects Appear To Be Opening Way For ANDAs
Executive Summary
Pre-ANDA meeting requests were high in some product categories where FDA conducted research projects, suggesting agency may influence sponsors' development priorities.
You may also be interested in...
BsUFA III: Reauthorization Process Begins With US FDA Considering Staffing, Uptake Issues
Biosimilar availability may not be in the its purview, but the FDA still is thinking about ways to help industry deal with the issue and support sector growth.
FDA And Industry Set Out GDUFA III Priorities
Both first-cycle approvals and priority assessment improvements have been the subject of questions and criticism as the FDA and industry attempt to boost generic competition.
GDUFA III: First-Cycle Approval, Priority Assessment Improvements Are Early Priorities
Both issues have been the subject of questions and criticism as the FDA and industry attempt to boost generic competition.