FDA Roundup: November 22, 2024

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Announcements"> Press Announcements </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-9" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <p class="content-type-label text-center">FDA News Release</p> <h1 class="content-title text-center">FDA Roundup: November 22, 2024</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-roundup-november-22-2024" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li 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Thursday, the FDA published the FDA Voices: “<a href="https://www.fda.gov/news-events/fda-voices/upholding-public-trust-fda-office-criminal-investigations-crucial-role-bringing-drug-criminals">Upholding Public Trust: FDA Office of Criminal Investigations’ Crucial Role in Bringing Drug Criminals to Justice</a>,” by Justin D. Green, MBA, MDiv., Assistant Commissioner, FDA Office of Criminal Investigations (OCI). For more than 30 years, OCI investigators have been conducting and coordinating criminal investigations of suspected illegal activities involving FDA-regulated products, arresting bad actors, and referring cases to the Department of Justice for prosecution. A recent OCI investigation led to the conviction of a Dallas anesthesiologist on four counts of tampering with consumer products resulting in serious bodily injury, one count of tampering with a consumer product and five counts of intentional adulteration of a drug. On November 20, 2024, he was <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/dallas-anesthesiologist-convicted-tampering-iv-bags-sentenced-190-years-prison">sentenced to 190 years</a> in federal prison.</li> <li>On Thursday, the FDA <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-announces-sufficient-capacity-test-mycotoxins-under-fsma-laboratory-accreditation-analyses-foods">reminded</a> owners and consignees of certain imported foods that, starting December 1, 2024, mycotoxin analyses must be conducted by accredited laboratories under the Laboratory Accreditation for Analysis of Foods (LAAF) program. For detailed information on the <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/laboratory-accreditation-analyses-foods-laaf-program-final-rule">LAAF final rule</a> and to access the <a href="https://datadashboard.fda.gov/ora/fd/laaf.htm">LAAF Dashboard</a>, please visit our website.</li> <li>On Thursday, the FDA announced a <a href="https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-communications-pilot-enhance-medical-device-recall-program">communications pilot</a> to enhance the medical device recall program. This pilot is intended to improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be the most serious type of recalls, but where the FDA may not yet have determined that the actions meet the regulatory definition of a recall. This effort aims to increase transparency and minimize the time between the FDA’s initial awareness of and public communication of potentially high-risk medical device removals or corrections, providing more timely communication to consumers and health care providers. This pilot demonstrates the important role of reflecting patient input in our regulatory efforts. The FDA takes seriously our role in communicating both the benefits and risks of medical devices, to support an informed public and strong health care system.</li> <li>On Thursday, the FDA updated the <a href="https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-o121h19-organic-carrots-november-2024">outbreak advisory</a> for E. coli O21:H19 infections linked to organic whole and baby carrots supplied by Grimmway Farms. The retail-packaged organic whole carrots were in stores for purchase from August 14 through October 23, 2024. The organic baby carrots have different best-if-used-by-dates ranging from September 11 through November 12, 2024. The update includes information about recalled product being distributed to markets outside the United States and additional recalls from companies that may have used or repackaged recalled carrots from Grimmway Farms. FDA’s investigation remains ongoing.</li> <li>On Wednesday, the FDA <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanidatamab-hrii-previously-treated-unresectable-or-metastatic-her2">granted</a> accelerated approval to Jazz Pharmaceuticals Inc.’s Ziihera (zanidatamab-hrii), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. The FDA also approved VENTANA PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (Ventana Medical Systems, Inc./Roche Diagnostics) as a companion diagnostic device to aid in identifying patients with BTC who may be eligible for treatment with Ziihera. The prescribing information contains a boxed warning for embryo-fetal toxicity. The most common adverse reactions reported in at least 20% of patients who received Ziihera were diarrhea, infusion-related reactions, abdominal pain, and fatigue.</li> <li>On Wednesday, the FDA issued this final guidance: “<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program-and-third-party-emergency-use-authorization-eua-review">510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review</a>”. This guidance supersedes the previous 510(k) Third Party Review Program guidance, clarifying how the FDA will use third party review organizations to review 510(k) submissions and may use them to review EUA requests during a future public health emergency.</li> <li>On Tuesday, the FDA published “<a href="https://www.fda.gov/drugs/our-perspective/our-perspective-omufa-past-current-and-future">From Our Perspective: OMUFA – Past, Current, and Future</a>”. The OTC Monograph drug user fee program, referred to as “OMUFA”, provides for funding to help support the Agency’s OTC monograph drug activities following modernization of the country’s OTC drug regulation system through OTC monograph reform enacted under the Coronavirus Aid, Relief, and Economic Security (CARES) Act. CDER’s Dr. Patrizia Cavazzoni and Dr. Theresa Michele, discuss the first years of the OMUFA program, as well as its future.</li> </ul> <h2>Related Information</h2> <div class="field field--name-field-related-information field--type-text-long field--label-above"> <div class="field--label">Related Information</div> <div class="field--item"><ul> <li><a href="https://www.fda.gov/news-events/fda-newsroom">FDA Newsroom</a></li> </ul> </div> </div> <p class="text-center">###</p> <div class="inset-column"> <div data-quickedit-field-id="node/423985/field_generic_long_text/en/full" class="field field--name-field-generic-long-text field--type-string-long field--label-above"> <div class="field--label">Boilerplate</div> <div class="field--item"><p>The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. 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FDA Roundup: November 22, 2024 | FDA