About FDA

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• (1) The monthly percentages are based on a denominator that excludes supplements that were withdrawn by the manufacturers prior to the due date.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 - 2012

Time	Target	Number
Oct 2011	N/A	2
Nov 2011	N/A	1
Dec 2011	N/A	4
Jan 2012	N/A	0
Feb 2012	N/A	1
Mar 2012	N/A	2
Apr 2012	N/A	12
May 2012	N/A	0
Jun 2012	N/A	5
Jul 2012	N/A	3
Aug 2012	N/A	13
Sep 2012	N/A	4

FY 2012 Total: 47

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

Fiscal Year - 2012

Time	Target	Number
Oct 2011	N/A	2
Nov 2011	N/A	1
Dec 2011	N/A	6
Jan 2012	N/A	0
Feb 2012	N/A	1
Mar 2012	N/A	3
Apr 2012	N/A	12
May 2012	N/A	1
Jun 2012	N/A	5
Jul 2012	N/A	3
Aug 2012	N/A	13
Sep 2012	N/A	5

FY 2012 Total: 52