is this why fda delays are getting longer?

The FDA site shows dozens of Label Revisions this month, but only 5 ANDA approvals (exluding the latest Dr Reddy's approval).

Perhaps herein lies one of the causes of FDA delays - Labeling Revisions are being applied for and pumped out left, right and centre.

It is understandable in our litigious society and very particular drug industry, that label revisions are a fact of life and are likely to just clog up the system even more as time goes by.

Perhaps the FDA needs to completely separate the approvals process (totally different staff) so that Label Revision applications cause no delays to any ANDAs.

With only 5 ANDA approvals (displayed) in the 10-11 working days this month, it appears that the bottleneck is not the number of ANDA applications.

Perhaps its a bit more complicated than this, but senior management at the FDA may not be able to "see the wood for the trees"