05
Jul
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OGD Updates the Other May 2022 Statistics

On July 1, OGD updated its monthly statistical report for May 2022 (here). The additional stats (while not particularly remarkable) outline the workload output for the ANDA review and approval process and should be of interest to most of us that pay attention to OGD output. Highlights of the final May statistical report appear below. […]

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16
Jun
Pattern obtained by superimposing black numbers on multicolored background. This is obtained by multiple colors paint watercolor technique on paper.

A Peek at Mid-Month June 2022 Approval Actions

June looks fairly strong but likely not as strong as May’s projected unofficial total (ninety‑three full and tentative actions).  With postings through June 14th on the FDA’s Daily and All Approval lists (here and here), as of 10:30 a.m. on June 16, 2022, there were twenty‑three full‑approval actions and nine tentative‑approval actions.  This total of […]

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26
Apr

By the Numbers – OGD Stats Explained and Other Topics

In today’s SBIA Generic Drug Forum, there were a number of presentations related to generic drug statistical reporting.  As someone who tracks OGD activities somewhat obsessively, these presentations validated many of the observations that I’ve been making in my blog posts on the OGD’s public statistical reporting. The presenters reviewed the types of required and […]

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21
Apr

Official Approval Numbers, CRLs, and New ANDAs for March Hit the OGD Stats Report

If we say so ourselves, we totally nailed the full-approval actions for March when we reported the unofficial number at sixty-three (see previous post here) but, at the same time, we missed big time on the tentative-approval actions, which we reported at four – well, the official TA approval actions were just reported at eighteen!  […]

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07
Apr
Pattern obtained by superimposing black numbers on multicolored background. This is obtained by multiple colors paint watercolor technique on paper.

Unofficial March 2022 Approval Action Estimates

March ANDA full‑approval actions (reported thus far) sit at sixty‑three, the second highest total this fiscal year (FY), eclipsed only by the sixty‑seven full‑approval actions in November.  That’s the good news!  The OGD only issued four tentative‑approval (TA) actions in March, the lowest number this FY (the previous range was eight in November to twenty‑two […]

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05
Nov

A Look at the Reporting Requirements Described in the GDUFA III Commitment Letter

The FDA is changing its reporting requirements for GDUFA III.  It appears from the changes that some information may be more difficult to gather and will be removed from the monthly Generic Drugs Program Activities Report we have all come to love and will be moved to either quarterly or annual reports. The monthly report […]

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31
Oct

OGD Published GDUFA III Commitment Letter

Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]

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