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 […]
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 […]
Lachman Consultant Services, Inc. is proud to be a Gold Sponsor of the 2023 PDA Robotics and Automation Conference. Taking place on Wednesday, May 3rd and Thursday, May 4th, 2023, in Amsterdam, The Netherlands, the two-day gathering builds a roadmap to digitization designed for drug manufacturing. This annual conference is designed to catalyze the transition […]
The CDER Small Business and Industry Assistance (SBIA) presented a two-day seminar on April 12-13, 2023, celebrating the first 10 years of GDUFA. With the Office of Generic Drugs and industry now operating under the third iteration of GDUFA, the presentations by FDA Agency covered a lot of ground in an effort to highlight the […]
With half of April in the books, the number of OGD approval actions posted as of April 14th includes twenty‑seven full‑approval actions and four tentative‑approval actions for a total of thirty‑one approval actions. It looks like the OGD is heading towards an average approval month for April. Average definitely isn’t a bad thing, especially since […]
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 […]
When we looked at the mid-month February approvals back on February 22 (here), we projected that February might be a slim month for full approvals and we were right. OGD issued a total of 46 approval actions in February, the lowest total for a month thus far this fiscal year (FY). Of the 46 full […]
