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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 - 2011

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TimeTargetPercent
Oct 201090100
Nov 201090100
Dec 201090100
Jan 201190100
Feb 201190100
Mar 201190100
Apr 201190100
May 201190100
Jun 201190100
Jul 201190100
Aug 201190100
Sep 201190100

FY 2011 Total: 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  • (1) The monthly percentages are based on a denominator that excludes supplements that were withdrawn by the manufacturers prior to the due date.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 - 2011
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TimeTargetNumber
Oct 2010N/A12
Nov 2010N/A13
Dec 2010N/A13
Jan 2011N/A19
Feb 2011N/A28
Mar 2011N/A34
Apr 2011N/A40
May 2011N/A6
Jun 2011N/A28
Jul 2011N/A11
Aug 2011N/A19
Sep 2011N/A14

FY 2011 Total: 237

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

Fiscal Year - 2011
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2010N/A12
Nov 2010N/A13
Dec 2010N/A16
Jan 2011N/A21
Feb 2011N/A28
Mar 2011N/A35
Apr 2011N/A40
May 2011N/A6
Jun 2011N/A37
Jul 2011N/A12
Aug 2011N/A19
Sep 2011N/A14

FY 2011 Total: 253

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.