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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 - 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 20129060
Aug 201290100
Sep 201290100

FY 2012 Overall: 99%

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  • (1) The monthly percentages are based on a denominator that excludes supplements that were withdrawn by the manufacturers prior to the due date.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 - 2012
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TimeTargetNumber
Oct 2011N/A16
Nov 2011N/A21
Dec 2011N/A53
Jan 2012N/A12
Feb 2012N/A17
Mar 2012N/A21
Apr 2012N/A14
May 2012N/A10
Jun 2012N/A27
Jul 2012N/A3
Aug 2012N/A9
Sep 2012N/A8

FY 2012 Total: 211

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

Fiscal Year - 2012
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2011N/A16
Nov 2011N/A21
Dec 2011N/A53
Jan 2012N/A12
Feb 2012N/A17
Mar 2012N/A21
Apr 2012N/A14
May 2012N/A10
Jun 2012N/A27
Jul 2012N/A5
Aug 2012N/A9
Sep 2012N/A8

FY 2012 Total: 213

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.