FDA Roundup: July 11, 2023

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Jul 11, 2023, 16:20 ET

SILVER SPRING, Md., July 11, 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 FDA's Center for Veterinary Medicine (CVM) detailed how it is working to stop illicit xylazine from entering the United States. The Center is working in partnership with other offices across the FDA and Department of Health and Human Services as part of a whole-of-government response to this critical and growing issue. In February, in coordination with FDA's Office of Regulatory Affairs, CVM took action to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the country.

On Monday, the FDA signed a Confidentiality Commitment (CC) with the Fish Quarantine and Inspection Agency (FQIA) of the Ministry of Marine Affairs and Fisheries of the Republic of Indonesia. The CC is an important first step towards preparing Indonesia to participate in a program designed to ensure the safety of shrimp exported to the United States.

On Friday, the FDA authorized marketing of Better Therapeutics' BT-001, a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy (CBT) to patients 18 years or older with type 2 diabetes. BT-001 provides CBT to help users who are under the care of a healthcare provider better adhere to behaviors that aid in the management of diabetes. BT-001 should be used adjunctively with standard of care.

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.

Additional Resources:

FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

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