Lachman CONSULTANTS - Bob Pollock先生 2014-06-05
编译：识林-椒 2014-06-08
Good News on Supplement Backlog Outlined at GPhA/FDA CMC Workshop
Written by Bob Pollock • June 05, 2014
The Office of Generic Drugs (OGD) is now receiving help from other CDER components in its battle to get the supplement backlog down. In May of 2013, OGD reported just fewer than 6000 supplements in its backlog. Today with a little help from their friends, the total supplemental backlog stands at less than 4000. The chart below prepared by OGD's Robert Iser illustrates the decline in the backlog in FY 2014 through April 2014.
What we don't know is how many of the actions that took the supplements off of the OGD clock were Complete Response letters versus approvals. With supplements arriving at an average of about 150 per month, the OGD-reported statistics do not provide the number of Complete Response letters to supplements or the number of supplemental approvals; thus, it is not possible to calculate how many of these supplements will make a new appearance in the pending column.
It is certainly clear that the assistance OGD has been getting is helping them turn the corner on the supplemental backlog and, to give you an idea of the help from a quantitative perspective, another one of Robert Iser’s charts tells an interesting story. Just know that the Office of Pharmaceutical Science-created Supplemental Review Team is concentrating on all pre-GDUFA supplements, while OGD chemists are tackling all post-GDUFA supplements.
Good luck, OGD, on continuing this effort successfully. We hope to see how this issue is progressing at the GPhA Fall Technical Workshop where we are likely to see how the rest of the fiscal year submissions and FDA actions change the numbers.
