My fingers were tired last night so I did not get to capture a highlight of the presentation made by Dr. Iilun Murphy, Director, Office of Generic Drugs, which is usually one of the biggest draws of this annual conference. So, let’s take a step back and provide you with some tidbits from her presentation. […]
While I can’t remember how many of these meetings I have attended over my 40 years, so far this rates with the best of them for a couple of reasons. AAM’s new President and CEO, John A. Murphy III, and we got to meet him for the first time. We profiled John in a previous […]
The official August 2024 statistical report was published by the FDA on October 17, 2024 (here). Let’s run through the numbers and then we’ll take a look at the mid-month approvals for October 2024 (the first month of the new Fiscal Year 2025). The official August approvals were a couple below what we had predicted when […]
It was just last week, on October 7, 2024, when we published a blog (here) titled FDA Planned OTC Monograph Actions. That post outlined the OTC monograph issues that the Agency was planning to address over the next three years. Well, obviously, the FDA must have had its eyes set on beginning efforts on the issue […]
Well, here we are at the end of Fiscal Year (FY) 2024 and, because we likely will not see official approval action totals for the last two months of the FY until sometime in November, we will take a stab at giving you the best estimate we can. For September, the unofficial approval actions look […]
According to a post yesterday (here), the Association for Accessible Medicines (AAM) Board of Directors has announced the appointment of John A. Murphy, III as the association’s President and Chief Executive Officer. Mr. Murphy will join AAM in October from the Biotechnology Innovation Organization (BIO) where he served as Chief Policy Officer. Mr. Murphy is a lawyer and, […]
It was on September 24, 1984 that Congress gave birth to the Drug Price Competition and Patent Term Restoration Act, also known today as Hatch-Waxman (at the time of the Act’s passage, it was called Waxman-Hatch because the Democrats were in power). For those of you who don’t remember or weren’t even born when Hatch-Waxman […]
Historically, and in most cases, industry knows that it will certainly be required to perform both fasting and fed bioequivalence studies on solid oral immediate-release products or it may have an option to seek a waiver of in-vivo bioequivalence requirements for BCS Class 1 drugs. However, a few days ago, the FDA published a listing of […]
Some of you have asked why we keep such a close eye on ANDA approval actions. It is a valid question. Knowing the importance of moving freight through the OGD comes from a combined 40+ years of experience, both in the OGD and in industry, and it is clear to me that this is the […]
The FDA has updated the original nitrosamine impurity guidance after publication last year of Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) (here), also known as the RAIL guidance, caused a few disconnects between the two guidances. Now that we’ve all had more time to carefully read and absorb the updates in the […]
