As Lester Holt says at the introduction of the last show segment on NBC Nightly News – “There’s good news tonight”.  The same might be said of the recently released GDUFA II Quarterly Performance Report (here).

The figures for the fourth quarter have some really good news.  First, the number of ANDA awaiting FDA action (the workload of ANDAs) is the lowest during the 5-year cycle of GDUFA II and stands at 1603. And was only the second time in the GDUFA II window that the figure was lower than the number of applications awaiting applicant action.   But the best news of all is that the median approval time for the action cohort has hit the lowest since OGD has been tracking this metric in GDUFA II.  It stands at 18.98 months.  Remember, the median is defined as half of the actions above and half below the median.

While FY 2022 mean ANDA approval time (30.72 months) stayed pretty much the same as FY 2021 (30.20 months), they both beat the three previous FY mean approval times of 33.48, 31.99, and 39.58 months, respectively. While mean and median approval times for ANDA approvals still show considerable variability from quarter to quarter and year to year, the overall trend seems to point to a reduction in the mean and median approval times.  Again, there are so many factors, like quality of application, number of review cycles, patent and exclusivity, complex generic ANDAs that play into approval times that the metrics for ANDA approvals don’t always tell the entire story.

Mean and median ANDA tentative approval times of 29.95 and 28.85 months are fairly consistent over the past 5 years, but I don’t put a lot of faith in touting these number because there are factors that can weigh heavily on when an ANDA can actually be tentatively approved, for instance for complex products, that I don’t really like to make any definitive statement as to the impact of the relevance in the tentative approval metrics.

Let’s just say that after 10 years of GDUFA, it looks like OGD continues to move in the right direction.