Approvals

13
Dec
First Month FY 2024 OGD Statistics Are Finally Available - Lachman Consultants Blog

First Month FY 2024 OGD Statistics Are Finally Available!

Almost two and a half months after the beginning of FY 2024, the first month of FY 2024 (October 2023) statistics appeared, almost like a Christmas present! And from the looks of the numbers, there is likely some coal in some of the statistical “stockings.” Let’s start with the Original ANDA approval numbers. The OGD did pretty […]

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01
Nov
Full FY 2023 ANDA Statistical Reports Arrived on November 1, 2023 –Let's Take a Look

Full FY 2023 ANDA Statistical Reports Arrived on November 1, 2023 – Let’s Take a Look!

First, let’s look at September 2023 statistics (end of FY 2023), then we will comment on the full FY stats. As we reported here, September looked to be a slow month, and it was. While we missed a few full-approval actions (we reported forty-one), the OGD actually issued forty-four, and ten tentative-approval actions. Remember, the Agency […]

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25
Oct
The Posting of ANDA Approval Actions Is Still a Problem - No Word on Time for a Fix

The Posting of ANDA Approval Actions Is Still a Problem – No Word on Time for a Fix

Once again, with October approval action postings surprisingly low, I confirmed that the FDA is still having trouble with its internal IT systems that generate this information and populate certain databases. While it does not appear to be impacting data regarding NDAs, the ANDA postings are spotty at best. The word came back from OGD […]

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05
Oct

The State of Biosimilars and Generics 2023

The title of this blog was also the title of the presentation given by Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, Center for Drug Evaluation and Research.  I just could not think of a better title!  It is like the State of the Union address but not as expansive.  Dr. Corrigan-Curay spoke to the […]

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15
Sep
If You Are Looking for ANDA Approvals for September, Be Patient - Lachman Consultants

If You Are Looking for ANDA Approvals for September, Be Patient

This is a follow-up to the blog post “Houston, We Have a Problem” (here), noting that, with the exception of the one ANDA approval on September 5, 2023, no other ANDA approvals have been posted to either the Daily Approvals or All Approvals FDA websites through today! As I mentioned in that blog post, this problem […]

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08
Sep
August 2023 Delivers for ANDA Approval Actions Unofficially - Lachman Consultants

August 2023 Delivers for ANDA Approval Actions (Unofficially)

We had predicted, based on mid-month statistics (here), that August would be a big month for approval actions and, boy, was it! The OGD issued ninety-six full-approval actions along with twelve tentative-approval actions for a total of 108 approval actions. This was the second biggest month in FY 2023, behind the 117 approval actions in March […]

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