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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 January 31, 2014

Fiscal Year - 2012

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TimeTargetPercent
Oct 201190100
Nov 201190100
Dec 201190100
Jan 201290100
Feb 201290100
Mar 201290100
Apr 201290100
May 201290100
Jun 201290100
Jul 201290100
Aug 201290100
Sep 201290100

FY 2012 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 - 2012
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TimeTargetNumber
Oct 2011N/A3
Nov 2011N/A0
Dec 2011N/A5
Jan 2012N/A8
Feb 2012N/A3
Mar 2012N/A14
Apr 2012N/A2
May 2012N/A5
Jun 2012N/A4
Jul 2012N/A9
Aug 2012N/A1
Sep 2012N/A5

FY 2012 Total: 59

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A3
Nov 2011N/A0
Dec 2011N/A5
Jan 2012N/A8
Feb 2012N/A3
Mar 2012N/A14
Apr 2012N/A2
May 2012N/A5
Jun 2012N/A4
Jul 2012N/A9
Aug 2012N/A1
Sep 2012N/A5

FY 2012 Total: 59

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A0
Dec 2011N/A0
Jan 2012N/A0
Feb 2012N/A0
Mar 2012N/A0
Apr 2012N/A0
May 2012N/A0
Jun 2012N/A0
Jul 2012N/A0
Aug 2012N/A0
Sep 2012N/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.