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Percentage of manufacturing supplements (CBE and CBE-30 day Supplements) with action due dates occurring during the month that were reviewed and acted upon within 6 months of receipt (PDUFA) (1)

Dictionary: Licensed manufacturers must submit a Changes Being Effected (CBE) or CBE-30 supplement to FDA for any change to a product that has a moderate potential to have an adverse effect on 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. Distribution of product made with the change may commence 30 days after FDA receipt of a CBE-30 supplement, or immediately upon FDA receipt of a CBE supplement. This measure will allow OCBQ to monitor its performance in issuing decisions for manufacturing supplements (CBE) 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• (1) The monthly percentages are based on a denominator that excludes supplements that were withdrawn by the manufacturers prior to the due date.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 (CBE and CBE-30 day Supplements) with action due dates occurring during the month that were reviewed and acted upon within 6 months of receipt (PDUFA)

Fiscal Year - 2010

Time	Target	Number
Oct 2009	N/A	55
Nov 2009	N/A	17
Dec 2009	N/A	23
Jan 2010	N/A	6
Feb 2010	N/A	22
Mar 2010	N/A	32
Apr 2010	N/A	8
May 2010	N/A	30
Jun 2010	N/A	43
Jul 2010	N/A	11
Aug 2010	N/A	20
Sep 2010	N/A	24

FY 2010 Total: 291

Total number of manufacturing supplements (CBE and CBE-30 day Supplements) with action due dates occurring during the month

Fiscal Year - 2010

Time	Target	Number
Oct 2009	N/A	55
Nov 2009	N/A	17
Dec 2009	N/A	23
Jan 2010	N/A	6
Feb 2010	N/A	23
Mar 2010	N/A	33
Apr 2010	N/A	9
May 2010	N/A	39
Jun 2010	N/A	43
Jul 2010	N/A	11
Aug 2010	N/A	20
Sep 2010	N/A	24

FY 2010 Total: 303