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U.S. Department of Health and Human Services

About FDA

Percentage of completed CBER action packages posted on the web within 30 days of complete action package receipt in OCOD (1)

Dictionary: An Action Package is a compilation of the key decision documents from the approval of original and supplemental biologics license application (BLA) or new drug application (NDA). The Food and Drug Administration Amendments Act (FDAAA) requires the posting of action packages on the FDA web site within 30 days of approval. OCOD is responsible for ensuring CBER action packages are reviewed for disclosure and posted on the agency's web site to conform to all pertinent requirements. Expedient posting of action packages will provide up to date information to the public.

Fiscal Year - 2011

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TimeTargetPercent
Oct 2010N/A-
Nov 2010N/A-
Dec 2010N/A-
Jan 2011N/A-
Feb 2011N/A-
Mar 201190100

FY 2011 YTD: 100%

Footnotes

  • (1) There were no action packages due to be posted in February, June, August, September, October, November, and December 2010, January and February 2011. Tracking against this measure did not begin until January 2010.

Number of action packages due to be posted this month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A0
Nov 2010N/A0
Dec 2010N/A0
Jan 2011N/A0
Feb 2011N/A0
Mar 2011N/A1

FY 2011 YTD: 1

Number of action packages that were posted on time (within 30 days) during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A-
Nov 2010N/A-
Dec 2010N/A-
Jan 2011N/A-
Feb 2011N/A-
Mar 2011N/A1

FY 2011 YTD: 1

Number of action packages that were not posted within 30 days during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A-
Nov 2010N/A-
Dec 2010N/A-
Jan 2011N/A-
Feb 2011N/A-
Mar 2011N/A0

FY 2011 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.