Based on a strong start to the month, the OGD has issued forty approval actions but only two tentative approvals based on information posted through September 20th. Sorry that this mid‑month review was a bit late; with about two‑thirds of the month gone, I don’t expect to see another month like those we’ve seen lately. So, maybe, we can expect in the area of low- to mid‑60s for both approval actions and tentative‑approval actions. That is, of course, unless approval actions start to fly off the desks of FDA reviewers in the last eight days of the month – you never know!
22
Sep