Report on PDUFA Goals: Procedural and Processing Goals

This section reports on a number of PDUFA II goals that had no precedent under PDUFA I. These goals relate to the IND phase of drug development and some aspects of the infrastructure of drug review. A detailed description of the goals, the annual performance targets, and definitions of terms can be found in Appendix B. This section reports on actions on items that occurred in FY 00.

Meeting Management:

• Meeting Requests: Notify requester of formal meeting in writing within 14 days of request.
• Scheduling Meetings: Schedule meetings within goal date or within 14 days of requested date if longer than goal date within 30 days of receipt of request for Type A meetings, 60 days for Type B meetings, and 75 days for Type C meetings.
• Meeting Minutes: Agency prepared minutes, clearly outlining agreements, disagreements, issues for further discussion and action times will be available to sponsor within 30 calendar days of meeting.

Clinical Holds: Respond to sponsor's complete response to a clinical hold within 30 days of receipt

Major Dispute Resolution: Respond to sponsor's appeal of decision within 30 days of receipt

Special Protocol Question Assessment and Agreement: Respond to sponsor's request for evaluation of protocol design within 45 days of receipt

	Total	Met Goal	Missed Goal7	Pending Within Goal8		% On Time9
On-time Goal					70%
CBER	0	0	0	0
CDER	128	107	3	18
Combined	128	107	3	18		97%

 

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