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 […]
Do you have an ANDA, supplement, or controlled correspondence in at FDA awaiting resolution of a nitrosamine impurity issue? Has it been months overdue? You are not alone. OGD has been silent on those submissions as they navigate the widely expanding nitrosamine issue. My first thought is what happened since 1984, when Hatch-Waxman was first […]
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 […]
Today we address what might seem like an ongoing problem with no end. I refer to the submission of unsolicited amendments by DMF holders during an ANDA review cycle. If the DMF holder is unaware of the status of an ANDA and they do submit an unsolicited amendment, it could delay the review cycle or […]
Lachman Consultant Services, Inc. (Lachman Consultants), recently completed the expansion of our existing operations in Ireland to support the growing demand for services in the European region. Operating under the name Lachman Consultants (Ireland) Limited, this expanded pharmaceutical quality and regulatory consultancy is the most recent development in our global expansion to better serve the […]
This is the second edition of the “Did You Know?” series featuring some of the lesser known (or at least widely known) aspects of the GDUFA III program changes and the impact on the generic drug industry. Today we will focus on elements of Pre-ANDA Development Program. GDUFA III has opened the door for additional […]
Those of us that have been in the trenches since the passage of Hatch-Waxman have seen the issue of adhesion and sensitization studies for transdermal delivery systems (TDS) change dramatically. Well, there are now two new guidance documents that take us to the next step in recommended adhesion and irritation/sensitizations (I/S) testing revisions. First is […]
To follow up on last week’s blog (here). I came across the Amicus Curiae brief filed by the Solicitor General in the Teva v Glaxo case regarding the skinny label provisions of the Hatch-Waxman Act. I thought you would be interested in reading the brief for this important case so here it is! Enjoy the […]
I’ve been blogging about the chilling and hugely negative impact that the court decisions in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., No. 18‑1976, have on the delicate balance between the generic and brand‑name industries struck by the Drug Price Competition and Patent Term Restoration Act of 1984 (better known as the Hatch-Waxman Act). I won’t recount the […]
