US FDA’s PDUFA VIII Ideas Could Include Creating Regulatory Science Research Program
Executive Summary
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.
You may also be interested in...
Minutes Matter: Why The US FDA Refuses To Record Formal Meetings
Given confusion sometimes emerges about the content of formal meeting minutes, recording the meetings would seem like an easy solution, but also could muddy the administrative record.
Minutes Matter: Why The US FDA Refuses To Record Formal Meetings
Given confusion sometimes emerges about the content of formal meeting minutes, recording the meetings would seem like an easy solution, but also could muddy the administrative record.
US FDA’s Oncology Divisions Have Been Providing Live Meeting Minutes For Years. Will Others Follow?
Oncology division officials summarize the agreements and discussions reached during formal meetings so there are no misunderstandings later. Sponsors want the practice used more widely by the FDA.