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U.S. Department of Health and Human Services

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Percentage of manufacturing supplements requiring prior approval with action due dates occurring during the month that were reviewed and acted upon within 4 months of receipt (1)

Dictionary: Licensed manufacturers must submit a prior approval supplement to FDA for any change to a product that has a substantial impact to have an adverse effect on the 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. FDA approval must be obtained prior to distribution of the product made with the change. This measure will allow OCBQ to monitor its performance in issuing decisions for manufacturing supplements requiring prior approval within established timeframes.

Information is current as of September 30, 2012

Fiscal Year - 2011

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TimeTargetValue
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 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  • (1) The monthly percentages are based on a denominator that excludes supplements that were withdrawn by the manufacturers prior to the due date.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 requiring prior approval with action due dates occurring during the month that were reviewed and acted upon within 4 months of receipt

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A3
Nov 2010N/A4
Dec 2010N/A1
Jan 2011N/A11
Feb 2011N/A4
Mar 2011N/A4
Apr 2011N/A33
May 2011N/A34
Jun 2011N/A6
Jul 2011N/A1
Aug 2011N/A9
Sep 2011N/A3

FY 2011 Total: 113

Total number of manufacturing supplements requiring prior approval with action due dates occurring during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A3
Nov 2010N/A7
Dec 2010N/A1
Jan 2011N/A11
Feb 2011N/A4
Mar 2011N/A4
Apr 2011N/A35
May 2011N/A34
Jun 2011N/A7
Jul 2011N/A1
Aug 2011N/A9
Sep 2011N/A3

FY 2011 Total: 119

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.