We are almost two months into FY 2015 and the first year of metrics for GDUFA, but have you noticed that the Generics Activity Report of the Generic Drug Program has not yet published for the October? As we understand it, the new OGD/CDER IT platform, noted by Dr. Woodcock as having some problems at the GPhA Fall Technical Workshop, is perhaps the culprit.
It is not known when the Activity Report will be published again, but the lack of access to its data certainly will give industry more heartburn when trying to make sense and track OGD’s progress in year one of the GDUFA metrics. While one can still view the number of approvals updated daily on a different CDER web site (oh, and by the way, so far this month there have only been 8 ANDA approvals through November 23), seeing the number of Complete Response Letters, the number of ANDA receipts and other critical information that was included in the monthly activity report appears to be on hold until the IT folks can figure out how to generate those report under the new IT platform. Sounds like the platform may be a bit shaky.
Until the new reports begin, the window on transparency at OGD closes a bit more. Let’s hope this temporary glitch can be corrected quickly so the industry can have a peek into the productivity of OGD.