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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

• FY 2010
• FY 2011
• FY 2012
• All

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• (1) The monthly percentages are based on a denominator that excludes supplements that were withdrawn by the manufacturers prior to the due date.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 - 2010

Time	Target	Number
Oct 2009	N/A	2
Nov 2009	N/A	4
Dec 2009	N/A	4
Jan 2010	N/A	12
Feb 2010	N/A	15
Mar 2010	N/A	2
Apr 2010	N/A	4
May 2010	N/A	1
Jun 2010	N/A	6
Jul 2010	N/A	2
Aug 2010	N/A	5
Sep 2010	N/A	2

FY 2010 Total: 59

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

Fiscal Year - 2010

Time	Target	Number
Oct 2009	N/A	2
Nov 2009	N/A	4
Dec 2009	N/A	4
Jan 2010	N/A	12
Feb 2010	N/A	15
Mar 2010	N/A	2
Apr 2010	N/A	4
May 2010	N/A	1
Jun 2010	N/A	17
Jul 2010	N/A	2
Aug 2010	N/A	5
Sep 2010	N/A	2

FY 2010 Total: 70