Hold the Presses – First Time OGD Report Issues


Today, the FDA released a new report titled Activities Report of the Generic Drugs Program (FY 2018) – GDUFA II Quarterly Performance (here) which has some new figures we have not seen in any form before.  The new information includes mean and median approval time by cohort action for both original and tentative approvals (see chart below).

FDA defines the mean and median approval time in months as “the difference between the first full approval (AP) date or the first Tentative Approval (TA) date, and the date the original application was accepted for filing divided by the average number of days per month (30.4375). The unit for each of these metrics is months.”

The specific cohort year data is not available, so this information is for all ANDAs approved (some of which have grown whiskers from before GDUFA I).  All in all, it is interesting information but does not really show the difference in approval times from some of the old, old ANDAs and those that have been submitted in each of the GDUFA I and GDUFA II (don’t expect there are many of those if any) cohort years.

It is more than we knew yesterday, although maybe not exactly what we would like to see quite yet.  The rest of the data has been presented in some manner either in the OGD dashboard or in the Monthly Activities reports issues by the Agency.