In an era of rapid technological breakthroughs, the incorporation of artificial intelligence (AI) into numerous industries is transforming the way in which we all work. AI has been shown to be a valuable tool for automating mundane processes and analyzing large datasets. However, as we embrace its potential, we must also address the cybersecurity threats […]
The new 2025 Fiscal Year (FY) looks like it is off to a great beginning with OGD unofficially issuing 61 full approval actions and 22 tentative approval actions for a total of 83 total approval actions. While the numbers look good, it should be noted that the only month in FY 2024 that had more […]
Water is a critical component used in the manufacture of pharmaceutical products, and it must meet specific quality standards in order to demonstrate that the water intended to be used for manufacture is suitable for its intended purposes. USP <1231> on Water for Pharmaceutical Purposes provides an overview of the different water types used in manufacturing, […]
Baxter Recovery and FDA Actions The FDA announced additional actions “to increase access to and supply of IV and peritoneal dialysis (PD) solutions following Hurricane Helene-related damage to Baxter International Inc.’s North Cove facility in Marion, North Carolina.” The FDA performed assessments to enable import of IV solutions and PD solutions from seven different Baxter […]
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. […]
