FDA Roundup: July 14, 2023

FDA News Release

• For Immediate Release: July 14, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• On Thursday, the FDA re-issued two temporary guidances originally published during the COVID-19 public health emergency (PHE) for certain regulatory requirements that involve onsite visits abroad under the FDA Food Safety Modernization Act (FSMA).FDA Updates Duration of Enforcement Discretion Policies in Two COVID-19 Era FSMA Guidances | FDA   
• On Thursday, the FDA announced its upcoming participation in the 2023 Pain in Animals Workshop to be held on September 26-27, 2023, in Bethesda, Maryland. The workshop is hosted by the National Institutes of Health to promote animal welfare and management of pain in animals and people.
• On Thursday, the FDA, the U.S. Department of Agriculture and the Department of Homeland Security made available the 120 Day Food and Agriculture Interim Risk Review, which provides a review of critical and emergent risks to the U.S. Food and Agriculture sector, as well as ways to mitigate those risks. This review will help inform the Federal Risk Mitigation Strategy, as outlined in the National Security Memorandum-16 (NSM-16).
• On Wednesday, the FDA released a public inventory of certain food ingredients that the agency has determined to have unsafe uses in food because they are unapproved food additives and lists of select chemicals in the food supply currently under the agency’s review. The FDA also released a conversation with experts about the agency’s work to enhance the assessment of ingredients in foods on the market. These resources are intended to provide more insight on the FDA’s post-market assessments. The FDA’s assessment of chemicals in the food supply is part of our commitment to food safety.
• On Wednesday, the FDA updated the Breakthrough Devices website to add data on 32 devices granted Breakthrough designation and 5 Breakthrough Devices authorized for marketing from January 1 to March 31, 2023. The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices while maintaining the FDA’s rigorous standards for device safety and effectiveness, reflecting our commitment to device innovation and protecting public health.
• On Tuesday, the FDA published a Spotlight on CDER Science that explores the role of patient-reported outcomes to assess frailty in patients with multiple myeloma. Frailty is an aging-related syndrome of cumulative physical and physiological decline. Frailty measures that use patient-reported outcomes can provide scientific information on a patient’s experience.