Manual of Standard Operating Procedures and Policies
Regulatory - Communication
|
Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants
|
SOPP 8101.1 |
Version #4 |
Date: May 18, 2007 |
Appendix 1: PDUFA 3 Meeting Performance Goals
| Meeting Type |
Target Date |
| Type A |
Should occur within 30 calendar days of receipt of request |
| Type B |
Should occur within 60 calendar days of receipt of request |
| Type C |
Should occur within 75 calendar days of receipt of request |
All meetings are to be scheduled within 14 days of receipt of complete meeting request.
