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U.S. Department of Health and Human Services

About FDA

Number of Best Pharmaceuticals for Children Act (BPCA) reviews completed in the month

Dictionary:
These measures has been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A3
Nov 2009N/A2
Dec 2009N/A1
Jan 2010N/A0
Feb 2010N/A0
Mar 2010N/A1
Apr 2010N/A3
May 2010N/A0
Jun 2010N/A0
Jul 2010N/A0
Aug 2010N/A0
Sep 2010N/A0

Number of Pediatric Research Equity Act (PREA) reviews completed in the month

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A4
Nov 2009N/A1
Dec 2009N/A1
Jan 2010N/A3
Feb 2010N/A0
Mar 2010N/A0
Apr 2010N/A2
May 2010N/A1
Jun 2010N/A0
Jul 2010N/A0
Aug 2010N/A3
Sep 2010N/A5

Number of combined BPCA/PREA safety reviews completed in the month

Measure was implemented starting January 2010

Fiscal Year - 2010

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Measure was implemented starting January 2010

TimeTargetNumber
Jan 2010N/A1
Feb 2010N/A0
Mar 2010N/A0
Apr 2010N/A4
May 2010N/A1
Jun 2010N/A0
Jul 2010N/A0
Aug 2010N/A0
Sep 2010N/A1

Number of safety reviews completed under the Pediatric Rule

Measure was implemented starting January 2010

Fiscal Year - 2010

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Measure was implemented starting January 2010

TimeTargetNumber
Jan 2010N/A1
Feb 2010N/A0
Mar 2010N/A0
Apr 2010N/A0
May 2010N/A0
Jun 2010N/A0
Jul 2010N/A0
Aug 2010N/A0
Sep 2010N/A0

Glossary

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.