You Just Have To Wait: FDA Can't Hurry PDUFA VI Guidances
Executive Summary
In response to stakeholder concern about multi-year schedule for patient-input guidance development, FDA says it only has a few experts and has to balance their time.
You may also be interested in...
FDA Ends Regularly Scheduled Patient-Focused Drug Development Meetings
After conducting 24 disease-focused meetings in five years, FDA moving to next phase of patient interaction under new user fee cycle.
Woodcock Wants Rapid Regulatory Policy Development
CDER Director says US FDA needs to develop statistical and other guidances faster to keep up with the pace of science and drug development.
Woodcock Wants Rapid Regulatory Policy Development
CDER Director says US FDA needs to develop statistical and other guidances faster to keep up with the pace of science and drug development.