FDA Roundup: March 29, 2024

SILVER SPRING, Md., March 29, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

On Thursday, the FDA made several updates to the Mammography Quality Standards Act and Program section on the FDA Website to enhance user experience and provide the most up-to-date information, including reordering and renaming the landing pages so the information is easier to find and updating and deleting old data to provide the public with current information.
On Thursday, the FDA launched the Searchable Tobacco Products Database, a new user-friendly list of tobacco products—including e-cigarettes—that may be legally marketed in the United States. The database is designed to serve the public—especially retailers—by providing this key information in a single location, with easy-to–use search capabilities. The database, which can be accessed here. The database will be updated on a monthly basis.
On Wednesday, the FDA authorized marketing of the Medline Autologous Regeneration of Tissue (ART) Skin Harvesting System, a first-of-its-kind handheld, semi-automated device intended to obtain skin tissue from a healthy (donor) site on a patient’s body and deposit it onto that patient’s wound where a skin graft would be appropriate. The device uses an array of thin needles to collect many small plugs of skin (micrografts) instead of using a blade to obtain a sheet of skin for the graft. This device enables health care providers to perform the harvesting and graft application process in a minimally invasive manner, using local anesthesia, and in a wider range of clinical settings than what is used for a typical skin graft.
On Tuesday, the FDA updated the advisory for the outbreak of E. coli O157:H7 linked to raw cheddar cheese. The outbreak has ended, and FDA’s outbreak investigation is closed. The FDA recommends not to eat, sell, or serve all sizes of RAW FARM-brand Raw Cheddar cheese blocks (with best by dates through 10/4/2024) and shredded cheese (with best by dates through 5/10/2024). The FDA and CDC will continue to monitor for additional illnesses, and this investigation may be reopened if additional cases are identified.
On May 13, 2024, the FDA’s Center for Drug Evaluation and Research, NIH’s National Center for Advancing Translational Sciences, and the Reagan-Udall Foundation will host a public workshop titled Natural History Studies and Registries in the Development of Rare Disease Treatments. The workshop will bring together rare disease patient advocates, academic researchers, regulated industry, and other key stakeholders to discuss considerations for the use of natural history study and registry data in rare disease drug development programs. This is a hybrid workshop with options to participate in-person at FDA’s White Oak campus or remotely.

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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, radiation-emitting electronic products, and for regulating tobacco products.