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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

Footnotes

• (1) The monthly percentages are based on a denominator that excludes supplements that were withdrawn by the manufacturers prior to the due date.