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U.S. Department of Health and Human Services

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Percentage of manufacturing supplements (CBE and CBE-30 day Supplements) with action due dates occurring during the month that were reviewed and acted upon within 6 months of receipt (PDUFA) (1)

Dictionary: Licensed manufacturers must submit a Changes Being Effected (CBE) or CBE-30 supplement to FDA for any change to a product that has a moderate potential to have an adverse effect on identity, strength, quality, purity or potency of the product as they may relate to the safety or effectiveness of the product. Examples of such changes include production process, quality controls, equipment, facilities, or responsible personnel. Distribution of product made with the change may commence 30 days after FDA receipt of a CBE-30 supplement, or immediately upon FDA receipt of a CBE supplement. This measure will allow OCBQ to monitor its performance in issuing decisions for manufacturing supplements (CBE) within established timeframes.

Information is current as of September 30, 2012

Fiscal Year - 2010

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TimeTargetPercent
Oct 200990100
Nov 200990100
Dec 200990100
Jan 201090100
Feb 201090100
Mar 201090100
Apr 201090100
May 201090100
Jun 201090100
Jul 201090100
Aug 201090100
Sep 201090100

FY 2010 Overall: 100%

Footnotes

  • (1) The monthly percentages are based on a denominator that excludes supplements that were withdrawn by the manufacturers prior to the due date.

Total number of manufacturing supplements (CBE and CBE-30 day Supplements) with action due dates occurring during the month that were reviewed and acted upon within 6 months of receipt (PDUFA)

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A55
Nov 2009N/A17
Dec 2009N/A23
Jan 2010N/A6
Feb 2010N/A22
Mar 2010N/A32
Apr 2010N/A8
May 2010N/A30
Jun 2010N/A43
Jul 2010N/A11
Aug 2010N/A20
Sep 2010N/A24

FY 2010 Total: 291

Total number of manufacturing supplements (CBE and CBE-30 day Supplements) with action due dates occurring during the month

Fiscal Year - 2010
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2009N/A55
Nov 2009N/A17
Dec 2009N/A23
Jan 2010N/A6
Feb 2010N/A23
Mar 2010N/A33
Apr 2010N/A9
May 2010N/A39
Jun 2010N/A43
Jul 2010N/A11
Aug 2010N/A20
Sep 2010N/A24

FY 2010 Total: 303

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.