Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA posted information on its website regarding the formula for COVID-19 vaccines for the 2023-2024 fall and winter seasons. The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition. This recommendation incorporates advisory committee input and is based on the totality of the available evidence to select the vaccine composition that the FDA anticipates will best protect public health. The agency anticipates the timely submission of the data and filings to support FDA action on updated COVID-19 vaccines, in order to make vaccines available this fall that meet our standards for safety, effectiveness and quality.
- On Thursday, the FDA granted accelerated approval to glofitamab-gxbm (Columvi, Genentech, Inc.) for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy. The prescribing information includes a Boxed Warning for serious or fatal cytokine release syndrome (CRS). Other warnings and precautions include neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity (ICANS), serious infections, and tumor flare. Glofitamab-gxbm should only be administered by a healthcare professional with appropriate medical support to manage severe reactions, including CRS. View full prescribing information for Columvi.
- On Thursday, the FDA released findings from a sampling assignment that collected and tested refrigerated, multi-commodity ready-to-eat (RTE) dips and spreads. The assignment sought to estimate the presence of Salmonella spp. and Listeria monocytogenes in these products as part of the FDA’s ongoing effort to proactively ensure food safety and remove adulterated product from the market. From March 2021 to January 2022, the FDA collected and tested a total of 747 samples of refrigerated, multi-commodity RTE dips and spreads that contain ingredients such as sesame, vegetables, cheese, and seafood. The agency detected Salmonella spp. in one sample of hummus and Listeria monocytogenes in three dip and cheese spread samples. The FDA worked closely with the manufacturers to remove the contaminated products from the market. The FDA will continue to sample RTE dips and spreads for pathogens as warranted to protect consumers.
- On Thursday, the FDA 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. Degenerative spondylolisthesis is a painful debilitating condition where one of the vertebra (a spinal bone) slips forward putting pressure on the bone below it, which can sometimes cause pain. Lumbar spinal stenosis is a condition where the space around the spinal canal is too narrow leading to pressure on the nerves of the spine causing numbness and pain that may be severe. The TOPS System is an implant that attaches to the spine. Unlike a spinal fusion procedure, the TOPS System is designed to allow motion in the lower (lumbar) spine and may also help reduce pain and help people return to normal activities.
- On Wednesday, the FDA extended the comment period for the Draft Guidance for Industry entitled “Questions and Answers About Dietary Guidance Statements in Food Labeling” that appeared in the Federal Register on March 27, 2023. The new deadline for comments is September 25, 2023. The FDA is extending the comment period by 90 days in response to multiple requests from stakeholders to allow additional time for interested persons to develop and submit comments. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2023-D-1027.
https://www.regulations.gov/docket/FDA-2023-D-1027.
- On Wednesday, the FDA also issued a 30-day procedural notice on its plans to conduct a study entitled “Quantitative Research on Front of Package Labeling on Packaged Foods.” The study is a follow up to focus groups conducted in 2022 to further explore consumer responses to various front-of-package labeling schemes. As part of the Paperwork Reduction Act, federal agencies are required to publish a notice in the Federal Register on each proposed information collection to give the public the opportunity to comment. The FDA is conducting this consumer research to help explore the development of a front-of-package labeling scheme, which is part of the National Strategy on Hunger, Nutrition, and Health, issued as part of the White House Conference held in September 2022 focused on ending hunger and reducing diet-related disease.
- On Tuesday, the FDA sent out a public health alert to advise restaurants and retailers not to serve or sell and consumers not to eat certain raw oysters from Dai One Food Co., Ltd, Republic of Korea potentially contaminated with Norovirus. As the FDA continues to monitor the investigation, we will provide additional information on further interstate distribution and provide assistance to states as needed. If contaminated oysters are found to have been distributed to additional states, we will update this public health alert.
- On Tuesday, the FDA issued the final guidance: Content of Premarket Submissions for Device Software Functions. The final guidance provides information regarding the recommended documentation sponsors should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. The guidance replaces FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005, and updates FDA’s thinking related to the risk-based approach to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions.
Facts about the final guidance
- This final guidance fulfills an FDA commitment in MDUFA V and is intended to provide clarity, simplicity, and harmonization with current best practices and recognized voluntary consensus standards.
- The final guidance takes a simplified risk-based approach to help determine the device’s Documentation Level, which is either Basic or Enhanced. The Documentation Level helps to identify the minimum amount of information that would support a premarket submission that includes device software functions.
Related Guidance Update
- The FDA intends to issue minor updates to the guidance Off-The-Shelf Software Use in Medical Devices as well as to certain device specific guidances to reflect and ensure consistency with the information conveyed within the final guidance.
Upcoming webinar on this guidance
- On July 20, 2023, the FDA will host a webinar for medical device manufacturers and other stakeholders interested in learning more about the final guidance and the recommendations for documentation sponsors should include in premarket submissions.
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