With just two months to go in FY 2022, the OGD has updated its July statistical report (here).  With the hold‑up on the FY 2023-2027 User Fee legislation, some at the Agency are getting a bit nervous about their job security and firms are scrambling to try to budget for FY 2023 user fee costs; however, nothing will be published on fees for GDUFA III (or any of the UFAs, for that matter) until the legislation is passed.

Anyway, let’s get back to the updated stats!  The OGD issued the fewest number of refuse‑to‑approve letters of this FY in July (two).  That should make the OGD feel better as the numbers were beginning to creep up.  In addition, there were forty‑eight acknowledgement letters sent to applicants for new ANDAs.  The drop back to the second lowest number indicates that the bolus of 125 ANDA received by the OGD in March has likely made it through the initial completeness and acceptability review process.

Of the sixty‑five full‑approval actions previously reported, seventeen (26.1%) were approved in the first review cycle; that is one of the best months reported for first‑cycle review this FY, but that number should be reaching 50% plus if we are going to see any significant improvement in first‑cycle reviews.  As for tentative‑approval actions, of the seventeen issued in July, three (or 17.6%) were completed in the first cycle.

Information requests were at the lowest level this FY in July at 291 (the average through ten months is 370.6).  But, at the same time, amendments submitted by industry were also the lowest at 152 (the ten‑month average is 211.8) as industry response to deficiencies seemed to slow (maybe July vacations?).  CBE supplements and prior‑approval supplements were in line with previous months with 668 and 98, respectively, being submitted.  July was the third month in a row where no requests for clarifications were submitted by industry.  That is a bit surprising based on the questions we routinely receive from clients.

And, finally, one stat that we seldom mention is the number of DMF reviews, which were at forty‑two this month, a relatively constant number over multiple fiscal years.  Just don’t want you to think that we ignore them, but we do try to hit the highlights!

The full monthly report can be seen at the link provided above.  It provides a happy hunting ground for us number junkies!