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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 December 31, 2014

Fiscal Year - 2015

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TimeTargetPercent
October – December 201490100
January – March 201590TBD
April – June 201590TBD
July – September 201590TBD

FY 2015 YTD: 100%

Footnotes

  • (1) This measure was tracked monthly from January 2010 through September 2012, and tracked quarterly from October 2012 through present.

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

Fiscal Year - 2015
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TimeTargetNumber
October – December 2014N/A15
January – March 2015N/ATBD
April – June 2015N/ATBD
July – September 2015N/ATBD

FY 2015 YTD: 15

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

Fiscal Year - 2015
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TimeTargetNumber
October – December 2014N/A15
January – March 2015N/ATBD
April – June 2015N/ATBD
July – September 2015N/ATBD

FY 2015 YTD: 15

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

Fiscal Year - 2015
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TimeTargetNumber
October – December 2014N/A0
January – March 2015N/ATBD
April – June 2015N/ATBD
July – September 2015N/ATBD

FY 2015 YTD: 0

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.