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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

Dictionary: Licensed manufacturers must submit a prior approval supplement to FDA for any change to a biologic 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 the 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 OBRR 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 - 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%

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 - 2010
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TimeTargetNumber
Oct 2009N/A15
Nov 2009N/A2
Dec 2009N/A2
Jan 2010N/A6
Feb 2010N/A7
Mar 2010N/A10
Apr 2010N/A11
May 2010N/A3
Jun 2010N/A5
Jul 2010N/A11
Aug 2010N/A10
Sep 2010N/A12

FY 2010 Total: 94

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

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

TimeTargetNumber
Oct 2009N/A15
Nov 2009N/A2
Dec 2009N/A2
Jan 2010N/A6
Feb 2010N/A7
Mar 2010N/A10
Apr 2010N/A11
May 2010N/A3
Jun 2010N/A5
Jul 2010N/A11
Aug 2010N/A10
Sep 2010N/A12

FY 2010 Total: 94

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.