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Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

Number of results: 28

	Item	Program	Office	Program Status	Type	Download
1	2012 Small Clinical Trials Course	OSMP	Office of Orphan Products Development	Completed	Key Projects
2	Membership and Recruitment	OSMP	Advisory Committee Oversight and Management Staff	Completed	Key Projects
3	FY 2010 "Do a Designation" Workshop	OSMP	Office of Orphan Products Development	Completed	Key Projects
4	Orphan Drug Designation Standard Operating Policy and Procedure (SOPP)	OSMP	Office of Orphan Products Development	Completed	Key Projects
5	Summary Report on the Pediatric Device Consortia Grant Program	OSMP	Office of Orphan Products Development	Completed	Key Projects
6	Humanitarian Use Device (HUD) Guidance	OSMP	Office of Orphan Products Development	Completed	Key Projects
7	Use of Extrapolation of Efficacy in Products Granted Pediatric Exclusivity	OSMP	Office of Pediatric Therapeutics	Completed	Key Projects
8	Use of Alternative Endpoints in Pediatric Clinical Trials	OSMP	Office of Pediatric Therapeutics	Completed	Key Projects
9	Number of presentations/participation at U.S. conferences, stakeholder meetings, and trainings during the month	OSMP	Office of Special Medical Programs	Active	Program Measures
10	Number of international outreach efforts during the month	OSMP	Office of Special Medical Programs	Active	Program Measures
11	Number of Guidances and Regulations Issued	OSMP	Office of Special Medical Programs	Active	Program Measures
12	Percentage of RFD decisions issued in the month reviewed within 60 days	OSMP	Office of Combination Products	Active	Program Measures
13	Total number of RFDs filed by OCP in the month	OSMP	Office of Combination Products	Active	Program Measures
14	Total number of inquiries received by OGCP within the month	OSMP	Office of Good Clinical Practice	Completed	Program Measures
15	Total number of orphan drug designation reviews completed in the month	OSMP	Office of Orphan Products Development	Active	Program Measures
16	Percentage of orphan drug designation reviews completed in 90 days or less	OSMP	Office of Orphan Products Development	Active	Program Measures
17	Percentage of orphan drug designation reviews completed in 120 days or less	OSMP	Office of Orphan Products Development	Active	Program Measures
18	Total number of orphan drug designation decisions that resulted in orphan designation in the month	OSMP	Office of Orphan Products Development	Active	Program Measures
19	Total number of HUD designation reviews completed in the month	OSMP	Office of Orphan Products Development	Active	Program Measures
20	Percentage of HUD designation reviews completed in 45 days or less	OSMP	Office of Orphan Products Development	Active	Program Measures
21	Cumulative and total number of pediatric devices that were provided assistance by Pediatric Device Consortia in the quarter	OSMP	Office of Orphan Products Development	Active	Program Measures
22	Number of internal safety meetings for pediatric products or issues in the month	OSMP	Office of Pediatric Therapeutics	Active	Program Measures
23	Number of product safety assessment meetings coordinated for public review in the month	OSMP	Office of Pediatric Therapeutics	Active	Program Measures
24	Number of medical products studied in children with pediatric safety labeling changes in the month	OSMP	Office of Pediatric Therapeutics	Active	Program Measures
25	Number of Pediatric Advisory Committee (PAC) related activities in the month	OSMP	Office of Pediatric Therapeutics	Active	Program Measures
26	Number of contacts with foreign regulators to discuss scientific, ethical or safety issues related to pediatrics in the month	OSMP	Office of Pediatric Therapeutics	Active	Program Measures
27	Number of contacts with the Pediatric Review Committee (PeRC), the review divisions, and other FDA colleagues to provide Pediatric Investigation Plan (PIP) information to inform internal discussions	OSMP	Office of Pediatric Therapeutics	Active	Program Measures
28	Number of publications	OSMP	Office of Pediatric Therapeutics	Active	Program Measures