The U.S. Food and Drug Administration (FDA) has provided a summary of recent news and updates from the agency. On Thursday, the FDA re-issued two temporary guidances that were originally published during the COVID-19 pandemic for certain regulatory requirements involving onsite visits abroad under the FDA Food Safety Modernization Act (FSMA). These guidances aim to provide clarity and flexibility to manufacturers and importers during the public health emergency.
Additionally, the FDA announced its upcoming participation in the 2023 Pain in Animals Workshop, which will be held in September in Bethesda, Maryland. The workshop, hosted by the National Institutes of Health, aims to promote animal welfare and the management of pain in both animals and humans.
In collaboration with the U.S. Department of Agriculture and the Department of Homeland Security, the FDA made available the 120 Day Food and Agriculture Interim Risk Review. This review provides an assessment of critical and emergent risks to the U.S. food and agriculture sector, as well as strategies to mitigate those risks. The findings of this review will be used to inform the Federal Risk Mitigation Strategy outlined in the National Security Memorandum-16.
The FDA also released a public inventory of food ingredients that have been determined to have unsafe uses in food because they are unapproved food additives. Additionally, the agency provided a list of select chemicals in the food supply that are currently under review. These resources aim to provide more insight into the FDA’s post-market assessments and commitment to food safety.
In an update to the Breakthrough Devices website, the FDA added data on 32 devices granted Breakthrough designation and 5 Breakthrough Devices that have been authorized for marketing. The Breakthrough Devices Program allows patients and healthcare providers to access innovative medical devices while maintaining the FDA’s rigorous safety and effectiveness standards.
In a recent publication, the FDA spotlighted the role of patient-reported outcomes in assessing frailty in patients with multiple myeloma. Frailty is an aging-related syndrome characterized by physical and physiological decline. Patient-reported outcomes can provide valuable scientific information on a patient’s experience with frailty.
Overall, the FDA’s recent updates and initiatives reflect its commitment to protecting public health and safety. The agency continues to address regulatory requirements during the ongoing pandemic, promote animal welfare, assess risks to the food and agriculture sector, enhance the assessment of food ingredients, facilitate access to breakthrough medical devices, and explore innovative approaches to patient care.
