FDA Roundup: January 26, 2024

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 announced a new website listing regulations for the Foods Program it plans to publish by October 2024 and longer-term regulations it is prioritizing for publication at a later data. The FDA also updated the list of guidance topics for the Foods Program that it is considering and expects to publish by the end of 2024.  
• On Thursday, the FDA announced the availability of a revised draft guidance for industry titled Conducting Remote Regulatory Assessments Questions and Answers. The draft guidance, once finalized, will describe how the FDA intends to use RRAs for FDA-regulated products. The revised draft guidance reflects the FDA’s consideration of comments to the July 2022 draft guidance, as well as revisions to align with recent changes in law concerning mandatory records requests. Comments may be submitted by March 26.
• On Wednesday, the FDA announced the availability of draft guidance for industry (GFI) #286 (VICH GL60) entitled, “Good Manufacturing Practice for Active Pharmaceutical Ingredients used in Veterinary Medicinal Products.” This draft guidance has been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), a program that aims to harmonize technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States. The draft guidance, once finalized, will facilitate international harmonization of Good Manufacturing Practices (GMP) inspections of facilities that manufacture APIs and starting materials for use in such products. It will also help manufacturers and regulators ensure that APIs meet the quality and purity characteristics that they are intended to possess. The FDA is seeking public comment on the guidance for 60 days from the date of publication in the Federal Register.
• On Wednesday, the FDA announced organizational changes within the Center for Devices and Radiological Health (CDRH). Effective immediately, CDRH’s Office of Strategic Partnerships and Technology Innovation (OST) has been elevated to a Super Office within the Center. The new structure allows the center, specifically OST, to be well-positioned and capable of adapting to and addressing future public health needs and challenges while continuing to advance the voice of patients, innovation and safety, regulatory science, and service excellence with our customers.
• On Wednesday, the FDA published its first video in an educational series focused on how food companies’ use of tech-enabled traceability can enhance food safety and protect consumers from foodborne illness. This video is a resource for food producers, technology providers, and other stakeholders interested in advancing food traceability concepts and supporting efforts to achieve end-to-end traceability throughout the food safety system, at low- or no-cost to the end user, as outlined in the New Era of Smarter Food Safety Blueprint.
• On Tuesday, the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) announced the recently accepted new submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. This new submission is the first artificial intelligence-based and digital health technology-based project and the first project in neuroscience to be accepted into ISTAND. Launched in 2020, ISTAND aims to support the development of novel drug development tools (DDTs) to be used in regulatory applications for new medical products.
• On Tuesday, CDER updated a warning for consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks. The agency continues to receive severe adverse event reports after use of Neptune‘s Fix products, including seizures, loss of consciousness and death. Neptune Resources, LLC has agreed to voluntarily recall all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir and Neptune’s Fix Tablets to the consumer level. Consumers, distributors and retailers that have these products should either dispose of them or return them to place of purchase immediately.
   

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