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 […]
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 […]
In late September, the FDA announced that Tirzepatide is no longer in shortage. However, last week, the Outsourcing Facilities Association, an industry compounding group, initiated a lawsuit to challenge the FDA’s decision. As a result, the FDA has paused any enforcement or regulatory action and will reevaluate whether the drug is actually in shortage based […]
As of October 10, 2024, pursuant to section 319(a) of the Public Health Service Act (PHS Act), Department of Health and Human Services (DHHS) Secretary Becerra has determined that public health emergencies (PHEs) resulted from the devastation caused by hurricanes Helene and Milton. Because of the disruption to the availability of certain parenteral products, the […]
Though the FDA had indicated previously that it would not extend the deadline for full implementation of Drug Supply Chain Security Act (DSCSA) requirements, discretion appears to have become the better part of valor. On June 13, 2024, we posted a blog about waivers that would be available for certain small dispensers, and yesterday the FDA […]
