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 […]
The FDA notice (here) states: “[T]he over-the-counter (OTC) monograph annual forecast is a nonbinding list, issued each year, of planned monograph activities that FDA intends to initiate over the ensuing 3 years.” When the new monograph system went into effect, it was designed to reduce time to decision making by eliminating the lengthy comment and […]
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 […]
There is a new proposed piece of legislation that appears to give approved holders of ANDAs the right to unilaterally revise their labeling to provide new safety information that is not found in the labeling of the reference listed drugs (RLDs). Over the years, many proposals have been put forward to change the way that […]
