FDA Roundup: July 7, 2023

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Jul 07, 2023, 16:24 ET

SILVER SPRING, Md., July 7, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

Today, the U.S. Embassy & Consulates in India published a news release highlighting "Operation Broader Sword," a multi-agency enforcement operation with the Government of India identifying illicit pharmaceuticals, devices, or precursor chemicals shipped using the international mail system. Partner agencies involved in the operation included the FDA, the U.S. Customs and Border Protection, Homeland Security Investigations, the Drug Enforcement Administration, and the U.S. Postal Inspection Service (USPIS), in collaboration with the Government of India's Directorate of Revenue Intelligence. Taking place in June 2023, the operation stopped over 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs, combination medical devices, and synthetic drug precursors from reaching American consumers.
On Thursday, the FDA updated its webpage on Dermal Fillers (Soft Tissue Fillers) to reflect information from reports of delayed onset inflammation such as swelling or redness that can develop near the dermal filler injection site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation is responsive to treatment or resolves on its own. The FDA encourages consumers and patients to discuss all treatment options, including dermal filler procedures, with their health care provider to understand the benefits and risks associated with the use of these medical devices.
On Friday, the FDA issued a Safety Alert advising consumers not to purchase or eat certain Everest Garam Masala, Everest Sambhar Masala, and Maggi Masala ae Magic spices because they have the potential to be contaminated with Salmonella.
This week, the FDA, Office of the Chief Scientist, Office of Regulatory Science & Innovation (OCS/ORSI) is pleased to announce several renewal awards and one new award for the Centers of Excellence in Regulatory Science & Innovation (CERSI) Program. The CERSI program was established to foster robust and innovative approaches to advance regulatory science through collaborative interactions with FDA scientific experts. The institutions in the CERSI program promote innovation in regulatory science through cutting-edge scientific research that supports FDA's regulatory science needs and may also provide regulatory science information sharing opportunities, such as lectures, workshops, courses, scholar awards, fellowships, and competitions.

The institutions were selected and awarded through a competitive process for a cooperative agreement under RFA-FD-23-004. Renewal awards were made to University of Maryland, Johns Hopkins University and Yale University in a partnership with Mayo Clinic, and University of California, San Francisco, in a partnership with Stanford University. A new award was made to the University of North Carolina, Chapel Hill, in a partnership with Duke University. The new Research Triangle CERSI also plans to partner with North Carolina State University and North Carolina Central University, a Historically Black College and University (HBCU) on research projects and regulatory science information sharing opportunities. The institutions in the CERSI program received awards up to $50M for 5 years.
Each month, the FDA Grand Rounds lecture series highlights a key public health challenge, and how the FDA is applying science and innovation to its regulatory activities. The agency invites you to attend the next presentation on July 13, 2023, from 12 to 1 p.m. EST, on the topic, "The Plasmid Puzzle: Finding Solutions in Salmonella." Kristina Feye, Ph.D., a research microbiologist at the National Center for Toxicological Research, will discuss the strengths and limitations of different next-generation sequencing platforms, the importance of plasmids in public health and across the One Health spectrum, and the different ways plasmids can impact the microbiome.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration