FDA,FY 2002 Performance Report for the Prescription Drug User Fee Act of 1992,Procedural and Processing Goals

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 A. This section reports on actions on items that occurred in FY 2002.

Meeting Management:

Meeting Requests: Notify requestor of formal meeting in writing within 14 days of request.

Scheduling Meetings: Schedule meetings within 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). If the requested date for any of these types of meetings is greater than 30, 60, or 75 days, as appropriate, from the date the request is received by the Agency, the meeting date should be within 14 days of the requested date.

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.

			Total	Met Goal	Missed Goal⁶	Pending Within Goal⁷	% On Time⁸
On-time Goal							90%
Meeting Requests		CBER	414	399	14	1
		CDER	1075	949	107	19
		Combined	1489	1348	121	20	92%
Scheduling Meetings	Type A	CBER	16	14	1	1
	Type A	CDER	35	24	10	1
	Type B	CBER	245	199	8	38
	Type B	CDER	402	281	112	9
	Type C	CBER	113	98	5	10
	Type C	CDER	582	549	25	8
	All	CBER	374	311	14	49
		CDER	1019	854	147	18
		Combined	1393	1165	161	67	88%
Meeting Minutes		CBER	291	250	14	27
		CDER	971	434	209	328
		Combined	1262	684	223	355	75%

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

	Total	Met Goal	Missed Goal⁶	Pending Within Goal⁷		% On Time⁸
On-time Goal					90%
CBER	122	112	3	7
CDER	52	31	18	3
Combined	174	143	21	10		87%

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

	Total	Met Goal	Missed Goal⁶	Pending Within Goal⁷		% On Tim⁸
On-time Goal					90%
CBER	4	4	0	0
CDER	8	8	0	0
Combined	12	12	0	0		100%

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 Goal⁶	Pending Within Goal⁷		% On Time⁸
On-time Goal					90%
CBER	3	2	0	1		;
CDER	245	196	23	26
Combined	248	198	23	27		90%

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