May 3, 2024 - FDA Roundup: May 3, 2024

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

• Today, the FDA announced the availability of draft guidance for industry (GFI) #290 (VICH GL61) entitled "Pharmaceutical Development" for veterinary drug products. This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). VICH is a trilateral program, officially launched in April 1996, which aims to harmonize technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives. In support of wider international harmonization of regulatory requirements, VICH guidelines are also available for use by other countries. The FDA is accepting public comments on the draft guidance.
• On Thursday, the FDA announced the public meeting, "Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials," to discuss approaches to developing drugs to treat the negative symptoms of schizophrenia and disseminate important regulatory considerations for programs designed to evaluate these drugs. The workshop will be August 16, 2024, both on-site and virtual. Registration is only required for on-site attendance. 
• On Thursday, the FDA published a final rule that revises certain pre-harvest agricultural water provisions for covered produce (other than sprouts) in Subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule. Specifically, this rule replaces the previous pre-harvest water microbial quality criteria and testing requirements for covered produce (other than sprouts) with requirements for systems-based, pre-harvest agricultural water assessments for hazard identification and risk management decision-making purposes.
• On Thursday, the FDA's Center for Devices and Radiological Health, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research announced the 2024 Regulatory Education for Industry (REdI) Annual Conference that will be held on Wednesday, May 29, 2024, and Thursday, May 30, 2024. There is no cost to register and registration is now open.
• On Thursday, the FDA's Office of Translational Sciences (OTS) within CDER published its 2023 annual report. The report organizes OTS' achievements by its core activities: drug development and regulatory review, substance use disorders, inspections, science and research, knowledge management, and outreach and communications efforts.
• On Wednesday, the FDA announced the issuance of warning letters to 14 online retailers for selling unauthorized e-cigarette products popular among youth. These warning letters cite the sale of disposable e-cigarette products marketed under popular brand names such as Elf Bar/EB Design, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars, and Lost Mary.
• On Wednesday, the FDA announced the qualification of a new tool to assess atrial fibrillation burden estimates within clinical studies through the Medical Device Development Tools (MDDT) program. The Apple Atrial Fibrillation History Feature is the first digital health technology qualified under the MDDT program, providing a non-invasive way to check estimates of atrial fibrillation (AFib) burden within clinical studies. The device is designed to be used as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation devices. It is also designed to be used throughout the clinical study, both before and after cardiac ablation treatment, to monitor a study participant's weekly estimate of AFib burden.
• On Wednesday, the FDA announced it was taking important steps to advance the FDA's regulatory process for intentional genomic alterations (IGAs) in animals. The agency released updated guidance documents that underscore the agency's commitment to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products to increase regulatory flexibility, predictability and efficiency. In addition, the agency established a memorandum of understanding (MOU) with the U.S. Department of Agriculture to clarify roles and responsibilities for regulation of IGAs in animals.
• On Tuesday, the FDA's Center for Drug Evaluation and Research (CDER) published the 2023 Office of New Drugs (OND) Annual Report, which captures the office's major achievements of 2023 to include notable drug approvals, guidances, publications, participation in meetings, workshops, webinars, conferences, and more. The 2023 OND Annual Report reflects the wide-ranging efforts of the office in supporting drug development, conducting extensive application reviews leading to important drug approvals, advancing policy through workshops and new guidances, and continuing to assure careful post-approval drug assessments.
• On Tuesday, the FDA issued an outbreak advisory for a multistate outbreak of E. coli O157:H7 infections linked to organic walnuts from Gibson Farms, Inc. of Hollister, California that were distributed to multiple natural food and co-op stores in AK, AR, AZ, CA, CO, HI, ID, KS, LA, MT, NE, NM, NV, OR, SD, TX, UT, WA, and WY and sold in bulk bins. On April 27, 2024, Gibson Farms, Inc. initiated a voluntary recall and contacted their distributing customers. Distributors and retailers that may have received recalled bulk organic walnuts should follow the recommendations in the advisory and contact their customers. A full list of store names and locations where recalled walnuts may have been sold is available. FDA is working with the firm and its distributors to determine whether additional store locations, products, or states are affected.
• On Tuesday, as part of its celebration of Asian American, Native Hawaiian, and Pacific Islander Heritage Month, the FDA announced the release of the latest episode of the Health Equity Forum Podcast: "Engaging Native Hawaiian Communities in Clinical Trials." In this episode, OMHHE Acting Director Dr. Christine Lee speaks with Dr. Todd Seto and Dr. Deb Taira of the Queen's Medical Center on their research with the Hawaii Health Equity Research and Outreach Network (Hawaii HERON). Dr. Seto and Taira's work with Hawaii HERON aims to address and reduce health disparities experienced by AA and NHPI communities.

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