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FDA Roundup: Key Updates from November 22, 2024

In a recent update, the U.S. Food and Drug Administration (FDA) provided an overview of important news and actions taken by the agency. Here are the highlights from November 22, 2024, showcasing the FDA’s ongoing efforts to ensure public safety and regulate health products effectively.

Upholding Public Trust

On November 22, the FDA published a significant piece titled "Upholding Public Trust: FDA Office of Criminal Investigations' Crucial Role in Bringing Drug Criminals to Justice," penned by Justin D. Green, Assistant Commissioner of OCI. Over the past three decades, the FDA’s Office of Criminal Investigations has diligently investigated and coordinated criminal inquiries into illegal activities concerning FDA-regulated products. Recently, their efforts culminated in the conviction of a Dallas anesthesiologist. This individual faced severe repercussions, receiving a sentence of 190 years in federal prison for multiple counts related to tampering with consumer products, resulting in serious bodily harm.

Mycotoxin Regulations Begin Soon

Starting December 1, 2024, the FDA will enforce new regulations requiring certain imported foods to undergo mycotoxin analyses. These tests must be conducted by laboratories accredited under the Laboratory Accreditation for Analysis of Foods (LAAF) program. To access more detailed information about these changes and to utilize the LAAF Dashboard, stakeholders can visit the FDA’s official website.

Improving Medical Device Recall Communications

In an innovative move, the FDA announced a pilot program aimed at enhancing the communication process during medical device recalls. This initiative seeks to provide timely updates regarding corrective actions by companies, especially during serious recalls that may not yet fit the official regulatory definition. Such a step is designed to keep consumers and healthcare providers informed about potential risks, thereby improving overall public health safety.

Update on E. coli Outbreak

The FDA has also updated its advisory concerning E. coli O21H19 infections linked to organic carrots supplied by Grimmway Farms. The advisory highlights the issue with retail-packaged organic whole carrots sold between August 14 and October 23, 2024. Furthermore, the update includes details on recalls concerning other companies that may have repackaged the affected products. The agency continues to investigate the situation to prevent future incidents.

Accelerated Approval for New Cancer Treatment

On a positive note, the FDA granted accelerated approval for Ziihera (zanidatamab-hrii) from Jazz Pharmaceuticals, designed for individuals with unresectable or metastatic HER2-positive biliary tract cancer. This approval was based on results confirmed by an FDA-approved test. Alongside, a companion diagnostic was also approved to identify patients eligible for this therapy. However, a boxed warning accompanies the prescribing information due to potential risks of embryo-fetal toxicity.

New Guidance on Third Party Reviews

The FDA released new guidance regarding the 510(k) Third Party Review Program and Emergency Use Authorization (EUA) review processes, superseding previous directives. This update is intended to clarify the role of third-party review organizations in evaluating submissions, particularly during public health emergencies.

OTC Drug Regulation Updates

Finally, the FDA published an informative piece titled "From Our Perspective OMUFA – Past, Current, and Future." This addresses the OTC Monograph drug user fee program, detailing its impact and future plans following the regulatory modernization initiated by the CARES Act.

Overall, the FDA’s updates from November 2024 reflect its commitment to fostering public trust and ensuring the safety of drugs, medical devices, and food products. The agency remains a pivotal player in advancing health regulations and responding to public health challenges actively.