The U.S. Food and Drug Administration (FDA) has provided an at-a-glance summary of news from around the agency. Here are some key highlights:
1. COVID-19 Vaccine Formulation for Fall/Winter 2023-2024: The FDA has advised COVID-19 vaccine manufacturers to develop vaccines with a monovalent XBB.1.5 composition for the upcoming fall and winter seasons. The agency expects timely submission of data and filings to support FDA action on updated COVID-19 vaccines.
2. Approval of Glofitamab-gxbm for Lymphoma: The FDA has granted accelerated approval to glofitamab-gxbm for the treatment of relapsed or refractory diffuse large B-cell lymphoma. The prescribing information includes a Boxed Warning for serious or fatal cytokine release syndrome (CRS).
3. Testing of RTE Dips and Spreads: The FDA has released findings from a sampling assignment that tested refrigerated, multi-commodity ready-to-eat (RTE) dips and spreads for the presence of Salmonella spp. and Listeria monocytogenes. Salmonella spp. was detected in one hummus sample, and Listeria monocytogenes was detected in three dip and cheese spread samples.
4. Alternative to Spinal Fusion: The FDA has approved the Premia Spine, Inc. TOPS System as an alternative to spinal fusion for the treatment of certain patients with degenerative spondylolisthesis with moderate to severe lumbar spinal stenosis. The TOPS System is designed to allow motion in the lower spine and reduce pain.
5. Extension of Comment Period for Dietary Guidance Statements: The FDA has extended the comment period for the Draft Guidance for Industry on Dietary Guidance Statements in Food Labeling. Interested individuals now have until September 25, 2023, to submit comments.
6. Study on Front-of-Package Labeling: The FDA has issued a 30-day procedural notice on plans to conduct a study on front-of-package labeling on packaged foods. This study aims to explore consumer responses to various labeling schemes as part of the National Strategy on Hunger, Nutrition, and Health.
7. Public Health Alert on Contaminated Oysters: The FDA has issued a public health alert advising against the consumption of certain raw oysters from Dai One Food Co., Ltd, Republic of Korea due to potential contamination with Norovirus.
8. Final Guidance on Device Software Functions: The FDA has issued the final guidance on the content of premarket submissions for device software functions. This guidance provides recommendations for the documentation sponsors should include in their premarket submissions to demonstrate the safety and effectiveness of device software functions.
These updates from the FDA aim to ensure the safety, effectiveness, and quality of various regulated products, including vaccines, medical devices, food products, and more. The agency continues to monitor and address public health concerns while encouraging stakeholders and the public to provide input and feedback on various regulatory matters.
