As of November 16, 2022, the OGD has published the issuance of thirty‑three full‑approval actions and four tentative‑approval actions. With Thanksgiving around the corner and the predictable number of staff off on PTO, the back‑end of November might not be as productive as the first half. We will keep an eye out and post an update on how the month looks in a couple of weeks.
As of today, the OGD has not yet issued its first Generic Drugs Program Activities Report – Monthly Performance for FY 2023, which will initially include the official numbers for October approvals, CRLs, and receipts of new ANDAs. With the changes that have come with GDUFA III, we are not yet sure just how the reporting scheme will change, which metrics will appear in that report, or whether some of the metrics will begin to be reported only on a quarterly basis. Once the first report is issued, we will outline any changes that appear.
