The pharmaceutical industry is entering a transformative era with the Food and Drug Administration’s (FDA) newly established pathway for nonprescription drug products with an Additional Condition for Nonprescription Use (ACNU), with the final rule announced in a December 2024 Federal Register Notice (here). This new rule aims to broaden consumer access to safe and effective […]
The logbook is the original audit trail mechanism as predicated in Eudralex, Volume 4, Chapter 4, Section 4.31. Is it too simple to automate or are we addicted to the simplicity of using them? Regardless, the industry struggles to automate the review of one of the simplest controls. In 2024, there were twenty-nine inspectional FDA 483s due to the […]
According to Fraiser Kansteiner’s article published on January 2, 2025 in Fierce Pharma (here), “Lilly on Wednesday filed a motion to intervene in a lawsuit brought by compounding industry group the Outsourcing Facilities Association (OFA) and compounder FarmaKeio Custom Compounding in U.S. District Court in Fort Worth, Texas.” As so the saga goes on. Lilly is […]
Just to add a little bit of folly, we have a short holiday poem for you to ponder! Due to the current uncertainty in the industry and the future leadership and priorities of the FDA, I’ve taken a somber tone in this season’s message. Maybe next year we can add some humor back into the […]
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 […]
