The Food and Drug Law Institute (FDLI) recently held its 2023 Annual Conference on May 17-18 in Washington, D.C. where professionals from the food, drug, medical device, biologics, and tobacco industries gathered to hear important updates and panel discussions from a distinguished group of industry and FDA speakers. The Conference commenced with keynote addresses by […]
With the generic product approvals currently listed through May 15th on the All Approvals website (here), OGD has issued 30 full approval actions and 10 tentative approval actions for the month of May so far. Hopefully this will bode well for total approvals for the full month. We do have a major holiday coming up […]
Coming off the March total of 117 (ninety‑six full approvals and twenty‑one tentative approvals), April’s numbers are good but fall short of any big records. April saw the OGD unofficially issue sixty‑four full‑approval actions and eleven tentative‑approval actions for a total of seventy‑five approval actions. If these figures hold firm when the official numbers are […]
In the post that was published yesterday (here) regarding the statistics for the first six (6) months of FY 2023, I promised to provide some OGD trends. And I failed to deliver. I guess when the pedal is pushed down too hard, and you are going too fast you get to the next intersection before […]
It seems unbelievable that we are now halfway through FY 2023 already. (Well, the stats are halfway through the year, even though we are in month eight (8) of the FY). Time really DOES go fast when you are having fun! And now with six (6) months of data, we can provide some trends and […]
March 2023 was an outstanding month for approval actions, with OGD unofficially issuing 123 total approval actions comprised of 95 full approval actions and 18 tentative approval actions. There were other months with 100 or more total approval actions, but we have not seen that level of approval productivity in a while. The record of […]
February is a short month in workdays and it may be the same for approvals. Through February 17th, the OGD has issued twenty‑five full‑approval actions and fourteen tentative‑approval actions. With only six reporting days left this month, unless there’s a big surge in the next few days, we may be looking at the fewest approval […]
Visit with Lachman Consultants in Griffin Foyer, Booth #4 at the AAM Annual Meeting. Lachman Consultants is a proud Business Exposition Sponsor of this yearly event that’s taking place at the JW Marriott Orlando Bonnet Creek Resort & Spa in Orlando Florida on February 13th-15th, 2023. Access!™ is where policymakers, influential speakers and industry leaders […]
As we have noted in previous posts, the OGD has two types of approval actions for the various categories of approvals and tentative approvals. What the heck does that mean? Well, let’s take an example from this month’s approval actions. On January 24, 2023, the OGD approved one fentanyl application; however, that single application had […]
The Office of Generic Drugs reports that it approved 64 applications that were designated for competitive generic therapy (GCT) program. Since its inception, the program has approved a total of 186 (2 thus far in 2023) applications with the GCT designation. For the 2022 FY, OGD approved 69 ANDA that had GCT designation. Remember that […]
