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U.S. Department of Health and Human Services

About FDA

Number of site visits completed in the quarter

Dictionary: Site visits (1 – 2 days on site) are conducted by an external peer review team. The team is composed of FDA Advisory Committee subject matter experts and other external scientific and clinical subject matter experts. The peer review team follows detailed criteria in conducting the scientific review. The team’s reviews are informed by detailed written information provided in advance of the site visit and supplemented by presentations by the subject CBER laboratory. After the visit, the peer review team prepares a detailed draft report including findings and recommendations, which is submitted to the relevant FDA/CBER Advisory Committee for review, possible modification and acceptance. Final site visit reports are then submitted to CBER for utilization in internal peer review assessments of affected scientists, programmatic decisions and resource allocation.

Information is current as of September 30, 2014

Fiscal Year - 2014

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TimeTargetNumber
October – December 2013N/A3
January – March 2014N/A0
April – June 2014N/A0
July – September 2014N/A0

FY 2014 Total: 3

Number of site visit reports that are finalized in the quarter

Fiscal Year - 2014

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TimeTargetNumber
October – December 2013N/A2
January – March 2014N/A4
April – June 2014N/A0
July – September 2014N/A0

FY 2014 Total: 6

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.