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 […]
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 […]
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 […]
A May 28, 2024 review article by Skylar Jeremias titled, “New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching” (here), supports the fact that switching between biologics and biosimilars or from one biosimilar to another does not present a problem. The article states “[S]ince the July 2022 publication of the first systematic review of biosimilar-to-biosimilar switching, the European […]
Container Closure Integrity (CCI) testing is a central aspect of contamination control for a product. Contamination control strategy begins with the design, qualification, and validation of a facility, equipment, and processes. Product containers and closures are a crucial element of contamination control. Package integrity is the ability of the package to prevent loss, maintain sterility, […]
On March 7, 2024, the FDA adopted ICH Guideline Q14 Analytical Procedure Development, which became official on November 1, 2023. This guidance complements updated ICH Guideline Q2(R2) Validation of Analytical Procedures, which also became official on November 1, 2023 and was adopted by the FDA on March 6, 2024. The Q14 guidance (here) combines a science- and risk-based approach […]
Is your firm preparing for the wave of AI regulations, laws, white papers, and regulatory guidances? As reported in a previous Lachman blog, EU Artificial Intelligence (AI) Act: Impact on Pharma and MedTech, laws are emerging, but can companies keep up with the pace? Last year, the EU did what the U.S. has not been […]
In 2022, there were six Warning Letters and five 483 observations for issues relating to Diethylene Glycol (DEG) and Ethylene Glycol (EG). In 2023, there were thirty-six Warning Letters and nineteen 483 observations for DEG and EG concerns. So far this year (mid-February 2024), there have already been three Warning Letters containing observations for DEG […]
