Another day, another early morning on the West coast. While I am an early riser, 5:30AM is even a chore for this old FDA-er! But here we go! The morning began at the AAM GRx-Biosims meeting with Dr. Sally Choe, Director of the Office of Generic Drugs, as she provided a current program summary. We […]
We all know you can’t be in two places at once (although it would certainly be handy at times). That applies to the Association for Accessible Medicines (AAM) meeting as well. While there are lots of good sessions, as a one-man band, some tough choices had to be made. Let’s tackle one of the most […]
While there is nothing like being together, the COVID pandemic has kept us apart and so it is for the AAM conference. Getting used to the format was easy but it ain’t the same! While there were some minor technical glitches, the conference went off without a major hitch. Dan Leonard, the new President and […]
Unofficially, it appears that FY 2021 is being kicked off by the highest number of approval actions in the last eighteen months. That’s right, it looks like the OGD will hit a total of at least ninety approval actions for October, which consist of at least seventy-seven full-approval actions and thirteen tentative-approval actions. Why do […]
The FDA updated the full FY 2020 stats sometime overnight and now we have a clear picture of how the FY shaped up. While it is not somewhere over the rainbow, it appears to be the new normal and that’s not too bad. Let us take a look! First, the Refuse-to-Receive (RTR) numbers are down […]
The FDA released its FY 2020 quarterly report of the Generics Drug Program late yesterday. By the numbers, mean approval times reported by quarterly cohort have not changed significantly from quarter to quarter, and are driven by the age of the applications ready for and approved in that quarter. The Generics program has approved more […]
Initially issued in draft in 2017, the document “Referencing Approved Drug Products in ANDA Submissions – Guidance for Industry” was issued in final today. It addresses the difference between the reference listed drug (RLD) (that must be cited as the basis of the ANDA submission) and the reference standard (RS), and provides details of how the […]
With just 6 days until Halloween, what does the prospect for Trick or Treat look like in the ANDA approval candy basket? So far, the reporting of approval actions looks like treats will be in the bag. As of approval actions reported through October 22, 2021 OGD has issued 50 full approval actions and 6 […]
FDA reported 70 full approval actions and 15 tentative approval actions in September for a total of 85 approval actions for the month. The 85 approval actions fell into the second most approval actions in FY 2020 behind only April’s total of 87. The full approval action in September was also the second highest this […]
On June 1, 2020, in Docket FDA-2020-N-1127 and published in the Federal Register, the Agency asked for public comment regarding updating and clarifying the types of patents that could be listed in the Orange Book (here). The document sought comments on two specific issues of continued interest: should patents be submitted to the FDA and […]
