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...
US FDA’s PDUFA VIII Ideas Could Include Creating Regulatory Science Research Program
With regulatory science research already funded for generic drugs and biosimilars, CDER Director Patrizia Cavazzoni wants a program for prescription drugs considered for the next user fee renewal.
GDUFA Research Impacting Generic Development, ANDA Approvals
Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.
GDUFA Research Impacting Generic Development, ANDA Approvals
Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.