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U.S. Department of Health and Human Services

About FDA

Percentage of approval letters reviewed for disclosure and posted on the web within 5 business days of receipt in OCOD, excluding days that the Web Content Management System (WCMS) is not operational. (1)

Dictionary: An approval letter is the document used to communicate CBER’s approval of original and supplemental biologics license applications (BLAs) or new drug application (NDAs). OCOD is responsible for ensuring CBER approval letters are reviewed for disclosure and posted on the agency's web site to conform to all pertinent requirements. Expedient posting of approval letters will provide up to date information to the public.

Information is current as of March 31, 2014

Fiscal Year - 2011

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TimeTargetPercent
Jan 201190100
Feb 201190100
Mar 201190100
Apr 201190100
May 201190100
Jun 201190100
Jul 201190100
Aug 201190100
Sep 201190100

FY 2011 Overall: 100%

Footnotes

  • (1) Beginning October 2012, this measure will be reported quarterly

Number of approval letters provided to OCOD for posting this quarter.

Fiscal Year - 2011
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TimeTargetNumber
Jan 2011N/A10
Feb 2011N/A3
Mar 2011N/A5
Apr 2011N/A4
May 2011N/A5
Jun 2011N/A8
Jul 2011N/A10
Aug 2011N/A2
Sep 2011N/A2

FY 2011 Total: 49

Number of approval letters that were posted on time (within 5 business days, excluding days WCMS is not operational) during the quarter.

Fiscal Year - 2011
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TimeTargetNumber
Jan 2011N/A10
Feb 2011N/A3
Mar 2011N/A5
Apr 2011N/A4
May 2011N/A5
Jun 2011N/A8
Jul 2011N/A10
Aug 2011N/A2
Sep 2011N/A2

FY 2011 Total: 49

Number of approval letters that were not posted within 5 business days, excluding days that WCMS is not operational.

Fiscal Year - 2011
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TimeTargetNumber
Jan 2011N/A0
Feb 2011N/A0
Mar 2011N/A0
Apr 2011N/A0
May 2011N/A0
Jun 2011N/A0
Jul 2011N/A0
Aug 2011N/A0
Sep 2011N/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.