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 […]
Remember the good old days, when a dosing spoon or cup was dispensed with liquid medication and a product in a prefilled syringe was just a drug? Well, we know now that those days are over, and maybe they should be. The presentation by three FDAers, Markham Luke, MD, PhD, Karyn L. Berry, MD, MPH, and […]
August was an even better month than we predicted in our post on September 8th (here). There were actually 98 (instead of 96) full approval actions and 12 tentative approval actions for a total of 110 approval actions. The two (2) approvals missed likely were at the end of the month when we first discovered […]
Just wanted to catch you up on a session related to generic drugs that I found particularly interesting presented by Edward “Ted” Sherwood, Director of Regulatory Operations, OGD, on some statistical metrics that are quite impressive. Among other things, the presentation outlined missed GDUFA goal dates, but was not inclusive of those misses for imminent […]
While most sponsors make direct payments for their user fees, if you are one of those that like to send the money via check or other non-electronic method, better make sure you take note of the new address for delivery of such payments. “The Food and Drug Administration (FDA) is providing notice that the courier […]
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 […]
In a rousing session at the AAM’s GRx-Biosims conference, Kurt Karst, J.D., Director, Hyman, Phelps & McNamara, Brian McCormick, J.D., M.H.S., Vice President and Chief Regulatory Counsel, Teva Pharmaceuticals, and Chad Landmon, J.D., Partner, Axinn, Veltrop & Harkrider LLP gave a presentation entitled 180-Day Exclusivity: What Is Past Is Prologue or, as they like to […]
Another beautiful fall day in Bethesda and a great start to this year’s conference. Since I can only be in one place at a time (although my wife would beg to differ), I will give you some highlights from day 1. And next year, you should attend this meeting as this is the premiere event for […]
According to the Office of Generics Drugs (OGD) September 29, 2023 announcement (here) on October 2, 2023 OGD will expand the types of face-to-face (FTF) meeting it will entertain. That is of course, if the government does not shut down on Sunday October 1, 2023. Prior to this announcement, and after the Covid emergency was […]
Senator Mullin and Booker yesterday introduced a bill (here ) to permit e-labeling (electronic package inserts) to eliminate paper waste and permit firms to provide the most updated information almost instantaneously. There was also a press release (here ) that explained once more what has been explained a number of times in the past. This […]
