FDA Update: Highlights from November 22, 2024

Today, the U.S. Food and Drug Administration is summarizing the latest updates from the agency:

• On Thursday, the FDA released the FDA Voices piece titled, “Upholding Public Trust: FDA Office of Criminal Investigations’ Crucial Role in Bringing Drug Criminals to Justice,” authored by Justin D. Green, MBA, MDiv., Assistant Commissioner of the FDA Office of Criminal Investigations (OCI). For over 30 years, OCI agents have been conducting inspections and interrogations concerning suspected illicit activities involving FDA-regulated products, resulting in arrests and referrals for prosecution to the Department of Justice. A recent case led to a Dallas anesthesiologist being convicted on multiple counts including tampering with consumer products that resulted in serious injury and sentenced to 190 years in prison.
• The FDA reminded stakeholders that from December 1, 2024, mycotoxin analysis for certain imported foods must be performed by accredited labs under the Laboratory Accreditation for Analysis of Foods (LAAF) program. More details about the LAAF final rule can be found on our website.
• A new communications pilot has been announced by the FDA to enhance medical device recall strategies. This initiative aims to improve how quickly the FDA can communicate about important corrective actions from companies that might lead to serious recalls. The goal is to ensure timely communication regarding potential high-risk removals or corrections, showcasing a commitment to patient-centered regulatory practices.
• The agency updated the advisory on E. coli O21:H19 infections linked to organic carrots provided by Grimmway Farms. The advisory includes updates on the products available between August 14 and October 23, 2024, and additional recalls related to the contaminated carrots. The investigation is still in progress.
• The FDA granted accelerated approval for Jazz Pharmaceuticals’ Ziihera (zanidatamab-hrii), a bispecific HER2-directed antibody intended for patients with previously treated, unresectable or metastatic HER2-positive biliary tract cancer. The approval includes consideration of the VENTANA PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody as a companion diagnostic tool. Caution is advised due to a boxed warning for embryo-fetal toxicity, with common adverse effects being diarrhea, infusion reactions, abdominal pain, and fatigue.
• A final guidance titled “510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review” was issued on Wednesday, providing clarity on using third-party review organizations to process 510(k) submissions and future EUA requests especially during public health emergencies.
• On Tuesday, the FDA released a report named “From Our Perspective: OMUFA – Past, Current, and Future.” This document discusses the OTC Monograph drug user fee program (OMUFA) that supports the FDA’s OTC drug activities post-regulation reform to modernize OTC drug regulations established under the CARES Act.

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