For those of you who follow the daily approvals page (here), on November 21, 2024, there was a flurry of supplemental labeling approvals listed for drug products that contain non-steroidal anti-inflammatory drugs (NSAIDs), from aspirin to Zipsor (diclofenac potassium). In today’s CDER Drug Safety-related Labeling Changes (SrLC), the new, revised warning that must be included was […]
Having been around the block more than a few times, the position of the FDA regarding pricing is clear. The Agency is not supposed to take pricing considerations into drug approval or enforcement decisions. However, there is controversy swirling around the FDA’s recent decision on the drug shortage for GPL-1 obesity medications and the practice […]
President-elect Donald Trump has selected Dr. Martin Makary to lead the Food and Drug Administration. Makary is a surgeon from Johns Hopkins who has been fairly outspoken regarding the Agency that oversees our drug and food supply. He appears to be critical of some of the Agency’s decision-making processes and it looks like he will insert […]
I remember being locked in for protection at the Parklawn Building at the FDA in the face of protests outside centering on the AIDS crisis and lack of speed in the approval of antivirals as the first time that I felt as though the FDA was really under attack. Obviously, the FDA came through in […]
The 2024 MedTech Conference in Toronto provided some great insights on what the future of medical devices can offer, particularly when utilizing AI technology. One area making great progress is the use of wearables. Who knew my Apple watch could be so useful?! There were multiple presentations on pairing wearable devices with mobile apps. This […]
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 […]
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 […]
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 […]
