Based on a Federal Register (FR) notice issued in December 2023 (here), the FDA has determined that ciprofloxacin 100 mg tablets taken in a three-day regimen to treat uncomplicated urinary tract infections are ineffective based on resistance developed over time to E. coli, the primary causative agent for uncomplicated UTIs (see previous post here). Since that time, […]
On May 1, 2024, the first version of USP General Chapter <1079.4> on Temperature Mapping for the Qualification of Storage Areas became official, and it is the fourth part of USP General Chapter <1079> on Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products, which also includes: USP General Chapter <1079.1> on Storage and Transportation […]
Yesterday’s pre-publication Federal Register Notice (here) announced the Prescription Drug User Fees Act (PDUFA) program fees to be charged to fee-paying new drug applications for FY 2025. As you will note from the chart below, the application fees increased, but the program fee decreased. It is interesting that the magnitude of the application fee increases were […]
Dealing with different product requirements is often difficult, especially when the regulation office or center may differ as well. Over the years, individual post-approval change requirements have been scattered in documents from different centers and, if you have a good enough memory, then maybe you picked the right reporting requirement based on the product and […]
In pharmaceuticals, maintaining product quality and safety is paramount. Visual inspection plays a vital role in detecting particulate matter and/or container/closure defects, though it may fall short in pinpointing the root cause of defects or material origins. To fortify visual inspection programs effectively, a comprehensive risk assessment serves as the foundational pillar. This blog delves […]
With the recent news of cuts in FDA funding (most recently reported by Zachary Brennan in an Endpoints News story entitled, “House Committee Raises Concerns on CDER-CBER Misalignment Amid 2025 Funding Markup” (here, subscription required), the question of FDA being asked to do more must be asked, as it now appears it will have to […]
I retired from the FDA about one year ago this summer. I have mixed feelings about my twenty-one years with the Agency, but I mostly reflect back on the good memories and the great people I had the pleasure to learn from and work alongside. I find myself pivoting to my second curve, as popularized […]
Each year, the Office of Pharmaceutical Quality (OPQ) releases a report on the state of pharmaceutical quality. This year’s report was released yesterday and can be found here. Every year we try to pick out key issues and highlight some of the statistics outlined in the report, and this year is no different! Some important […]
The current state of drug shortages in the supply chain is under continued pressure, both outside of and within the U.S. According to the FDA, there are currently 105 products in shortage in the U.S. (here) as of the drafting of this blog. Not only are the shortages continuing, but adherence to section 506C of the […]
It’s fascinating to see the evolution and potential future of visual inspection in the pharmaceutical industry. The shift from manual methods to cutting-edge automated systems with artificial intelligence has significantly improved efficiency, accuracy, and reliability in product inspections. By leveraging AI technology in visual inspections, pharmaceutical companies can benefit from enhanced defect detection capabilities, greater […]
