The U.S. Food and Drug Administration (FDA) has released a summary of recent news and updates from the agency. One of the highlights is “Operation Broader Sword”, a joint enforcement operation between the U.S. and the Government of India to identify and stop the shipment of illicit pharmaceuticals, devices, and precursor chemicals through the international mail system. The operation successfully stopped over 500 shipments that contained unapproved prescription drugs, combination medical devices, and synthetic drug precursors.
In another update, the FDA has updated its webpage on Dermal Fillers to include information on delayed onset inflammation that can occur near the injection site. This inflammation can be a result of viral or bacterial illnesses, infections, vaccinations, or dental procedures. The FDA advises consumers to discuss all treatment options, including dermal filler procedures, with their healthcare provider to understand the risks and benefits.
The FDA also issued a Safety Alert advising consumers not to purchase or eat certain spices, namely Everest Garam Masala, Everest Sambhar Masala, and Maggi Masala ae Magic, due to potential contamination with Salmonella.
Additionally, the FDA announced renewal and new awards for the Centers of Excellence in Regulatory Science & Innovation (CERSI) Program. The CERSI program aims to promote innovation in regulatory science through collaborative interactions with FDA scientific experts. Renewal awards were granted to University of Maryland, Johns Hopkins University, Yale University in partnership with Mayo Clinic, and University of California, San Francisco in partnership with Stanford University. A new award was given to the University of North Carolina, Chapel Hill, partnering with Duke University. These institutions will receive funding for 5 years to support research and regulatory science initiatives.
The FDA Grand Rounds lecture series, which highlights key public health challenges and the FDA’s approach to regulatory activities, will be hosting a presentation on July 13, 2023, titled “The Plasmid Puzzle: Finding Solutions in Salmonella.” The speaker, Kristina Feye, Ph.D., will discuss the role of plasmids in public health and the microbiome, as well as the different sequencing platforms used in research.
Overall, the FDA is working diligently to ensure the safety and effectiveness of products within its jurisdiction, whether it be through enforcement operations, updated information on medical procedures, safety alerts, or collaborations with academic institutions.
