19
Aug

Mid-Month Peak at August 2022 ANDA Approval Actions

Well, we just passed the midway mark for August 2022 and it looks like a potentially good month for ANDA approval actions.  Thus far (at least posted through August 16th), the OGD has issued thirty full-approval actions and eleven tentative-approval actions, well on its way to a high-70s or low-to-mid-80s number of approval actions. We […]

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11
Aug

Official ANDA Approval Numbers, CRLs, and Original New ANDA receipts for July 2022 Reported

July looks like another good month for OGD approval actions with a reported sixty‑five full‑approval actions and thirteen tentative‑approval actions.  In a previous blog post, we reported sixty‑five and twelve in our unofficial counts (here).  That darn additional TA was posted after our blog post (so close!).  So, the OGD hit over the seventy‑mark again […]

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03
Aug

OGD Updates June 2022 Statistics

With just three months left in FY 2022, the OGD provided its update, adding the rest of the June statistics.  We now have a full picture of the first three quarters of the metrics provided in the FDA Generic Drugs Program Activities Report – Monthly Performance. Here are some highlights of the complete June report […]

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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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20
Jul

Everything You May Want to Know About Therapeutic Equivalence (and More!)

While most of us old timers grew up with Therapeutic Equivalence (TE) after the passage of Hatch-Waxman, the newly released draft guidance on TE (here) should be a good primer or refresher for most interested parties.  There may also be some things you did not know, like how a 505(b)(2) application can request a TE […]

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19
Jul

Unofficial July 2022 OGD ANDA Approval Numbers– Worry About the UFAs

July had some fireworks early in the month, and when the smoke cleared on July 15th, the OGD reported twenty‑nine full‑approval actions and seven tentative‑approval actions (thirty‑six in total).  If this pace continues, the OGD should surpass seventy total approval actions again this month.  For the nine months already officially in the books, six of […]

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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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