Well, OGD has snuck in one additional full approval and one additional tentative approval from the unofficial numbers we reported on September 6th (here). So, in actuality, FDA full approval actions for August were 75 and tentative approval actions were 22 for a whopping total of 97 (2 more than we found in available public […]
At the first in person PDA/FDA Joint Regulatory Conference since the pandemic began, (held September 12-14 in Washington, DC), it was almost impossible to escape the effect that the pandemic had on everyone attending the meeting, regardless of their affiliation. From the inevitable exclamation from presenters at the podium about how great it was to […]
The FDA released a draft guidance titled Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products: Guidance for Industry (here) which, not surprisingly, addresses the requirements for statements of identity and strength designations on the principal display panels (PDPs) of OTC drug products. The guidance notes that “[T]he […]
The nation has been struggling with drug abuse for as long as I can remember. The current opioid crisis keeps the problem on the front page, especially with fentanyl being disguised in a drug of abuse which has become one of the most deadly drugs of abuse in the long war on drugs. FDA has […]
With just two months to go in FY 2022, the OGD has updated its July statistical report (here). With the hold‑up on the FY 2023-2027 User Fee legislation, some at the Agency are getting a bit nervous about their job security and firms are scrambling to try to budget for FY 2023 user fee costs; […]
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 […]
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 […]
With a flurry of approvals at the end of the month, the unofficial count of approval actions for July 2022 breaks out as follows: 65 full approval actions and 12 tentative approval actions, for a total of 77 approval actions. This is the 7th out of 10 months that the total approval actions have broken […]
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 […]
Today in a prepublication Federal Register notice, (due to be published tomorrow), the FDA announced the addition of 29 new and 19 revised product specific guidance (PSG) documents. The Agency acknowledges that, “as part of FDA’s commitments under the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), FDA will publish guidances for reference […]
