When addressing the requirements of analytical test procedures, 21 CFR 211.160 states: “Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.” 21 CFR […]
A pre-publication Federal Register notice today (here) announced the first group of product-specific guidances (PSGs) for which the requirement for a fed, in-vivo bioequivalence (BE) study has been removed. In some instances, the fasting, in vivo bioequivalence requirements were modified such that now only one in vivo study will be required to support a bioequivalence […]
On the last day of GRx+Biosims, David Gaugh, Executive Vice President of AAM, had a fireside chat with Robert Califf M.D., commissioner of the Food and Drug Administration. The Commissioner’s comments echoed many of the themes discussed by other industry and FDA participants during the meeting, especially regarding the worry about sustainability of the generic […]
As Bob has previously blogged on the highlights from AAM day by day, let me take a moment to dive a bit deeper into one of the sessions. As an attendee of this meeting for several years, one of the best things about AAM’s GRx+Biosims is that sessions at this meeting often offer a mix […]
It is the last day of the conference, and we have some highlights for you. In a keynote address, Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, Center for Drug Evaluation and Research provided a State of the Biosimilars and Generics Program. By the numbers she indicated that in Fiscal Year (FY) 2024 OGD: Has […]
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 […]
