On September 30, 2023, the Animal Drug and Animal Generic Drug User Fee Amendments of 2023 were signed into law as part of H.R. 5860. The amendments reauthorize the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) programs administered by the U.S. Food and Drug Administration until 2028. But not […]
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 […]
ISPE 2023 Annual Meeting Mandalay Bay Resort Las Vegas, NV October 16th – 18th, 2023 We are looking forward to seeing you at the 2023 ISPE Annual Meeting & Expo. This annual event will usher in a revitalized focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing. MEET WITH LACHMAN CONSULTANTS AT BOOTH […]
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 […]
The session on nitrosamine impurities was held during the final breakout session on Wednesday morning during the final day of the conference. This session had the largest panel by far of those assembled on any topic presented at the conference, with 15 total panelists including the session moderator! It was even more difficult than usual […]
Well, folks, it looks like the FDA got its ANDA approval posting computer glitch fixed, but even that does not seem to guarantee good news. The FDA issued forty-one full-approval actions and ten tentative-approval actions for (an obviously low) total approval actions of fifty-one. That is the lowest number of full-approval actions since December of […]
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 […]
