FDA Updates: July 11, 2023

The U.S. Food and Drug Administration (FDA) has provided an update on various activities happening within the agency. One of the main focuses is the prevention of illicit xylazine from entering the United States. The FDA’s Center for Veterinary Medicine (CVM) is working in collaboration with other FDA offices and the Department of Health and Human Services to address this growing issue. In February, the CVM took action to restrict the unlawful entry of xylazine into the country.
Additionally, the FDA has 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. This commitment is a step towards preparing Indonesia to participate in a program that ensures the safety of shrimp exported to the United States.
Another development is the FDA’s authorization of Better Therapeutics’ BT-001, a prescription-only digital therapeutic device. The device provides cognitive behavioral therapy (CBT) to patients with type 2 diabetes, helping them better adhere to behaviors that aid in the management of the disease. BT-001 should be used in conjunction with standard care.
Every month, the FDA hosts the Grand Rounds lecture series, which focuses on key public health challenges and how the agency applies science and innovation to its regulatory activities. The upcoming presentation on July 13, 2023, titled “The Plasmid Puzzle: Finding Solutions in Salmonella,” will discuss the importance of plasmids in public health and how different next-generation sequencing platforms can impact the microbiome.
As a reminder, the FDA is an agency within the U.S. Department of Health and Human Services and its main role is to protect public health. The FDA is responsible for assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products, as well as medical devices. The agency also regulates the safety and security of the nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and tobacco products.