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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 - 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 201290100
Aug 201290100
Sep 201290100

FY 2012 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 - 2012
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TimeTargetNumber
Oct 2011N/A8
Nov 2011N/A7
Dec 2011N/A9
Jan 2012N/A12
Feb 2012N/A5
Mar 2012N/A15
Apr 2012N/A10
May 2012N/A3
Jun 2012N/A6
Jul 2012N/A11
Aug 2012N/A3
Sep 2012N/A4

FY 2012 Total: 93

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

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

TimeTargetNumber
Oct 2011N/A8
Nov 2011N/A7
Dec 2011N/A9
Jan 2012N/A12
Feb 2012N/A5
Mar 2012N/A15
Apr 2012N/A10
May 2012N/A3
Jun 2012N/A6
Jul 2012N/A11
Aug 2012N/A3
Sep 2012N/A4

FY 2012 Total: 93

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.