26
Sep

Sally Choe OGD Director Leaving!

According to Zachary Brennan’s story on Endpoints (here),  Sally Choe will be leaving OGD in two weeks coinciding with the end of GDUFA II and the beginning of GDUFA III.  The interim Director will be Susan Rosencrance “who’s currently director of the FDA’s Office of Lifecycle Products in the Office of Pharmaceutical Quality and has […]

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06
Sep

OGD Approval Actions – New High For FY 2022 (Unofficial Totals)

It appears that the OGD has hit a new high for total approval actions in August, judging by the unofficial numbers gathered from the available FDA databases as of this morning. Yes, that’s right-a total of ninety-five approval actions (seventy-four full-approval and twenty-one tentative-approval actions), which eclipses the ninety-four total full- and tentative-approval actions (eight-four […]

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22
Jul

Generic Drugs Quarterly Activities Report – Third Quarter FY 2022 Results

For each FY quarter, the OGD publishes a series of metrics (as agreed to in the GDUFA II commitment letter) that identify the FDA’s workload by indicating the number of ANDAs awaiting the OGD’s action, including new ANDAs submitted each month, with separate line‑items for tentatively approved (TAed) ANDAs awaiting approval (the FDA’s current ANDA workload) […]

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05
Jul
Countdown numbers flip counter. Vector isolated 0 to 9 retro style flip clock or scoreboard mechanical numbers set black on white

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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