FDA Roundup: January 9, 2024

SILVER SPRING, Md., Jan. 9, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

    --  On Jan. 10, please join OCE at 2:00 pm for Conversations on Cancer:
        Bringing Innovation to People Facing Cancer. This discussion will
        highlight oncology drug approvals in 2023. We will review a wide range
        of cancers, approval of novel drugs, and new uses for previously
        approved drugs. The discussion will focus on the most transformative
        oncology drug approvals for 2023 and showcase OCE's commitment to
        protecting and advancing patient care through approval of life-altering
        treatments for cancer patients. Registration Link:
        https://www.surveymonkey.com/r/FTYFN3H. The livestream YouTube link
        provided upon registration.


    --  Today, the FDA issued a Letter to Health Care Providers to alert
        providers and facilities about the potential for exposure to certain
        chemicals that may be released when General Electric (GE) HealthCare
        accessory components called the EVair or Evair03 compressor are used
        with certain ventilators, and to help ensure providers are aware of the
        manufacturer's recall notice and recommended actions.


    --  On Monday, the FDA updated the final guidance: Submission and Review of
        Sterility Information in Premarket Notification (510(k)) Submissions for
        Devices Labeled as Sterile. The FDA now considers vaporized hydrogen
        peroxide (VHP) as an Established Category A sterilization process. The
        updated guidance provides industry with revised recommendations on the
        information to provide in future 510(k) submissions that use VHP.


    --  On Monday, the FDA announced a town hall entitled, Medical Device
        Sterilization Town Hall: Overview of Sterilization Landscape and Role of
        Ethylene Oxide. This town hall will be held on Wednesday, January 10,
        2024, at 2:00 p.m. ET and will discuss takeaways from the 2019 Advisory
        Committee meeting focused on ethylene oxide sterilization (EtO), the
        current medical device sterilization landscape, supply chain integrity,
        and the need for forward-looking, innovative and collaborative
        activities.


    --  On Monday, the FDA's Coordinated Outbreak Response & Evaluation (CORE)
        Network released its first annual report summarizing its investigations
        of outbreaks and adverse events linked to FDA-regulated human foods for
        the 2022 calendar year. The FDA's CORE Network was established in 2011
        with the mission to find, stop, and prevent foodborne illness outbreaks.
        This is accomplished through disease surveillance, outbreak response,
        post-response activities, and collaboration with CDC and state and local
        public health agencies. Every year, CORE evaluates and responds to
        numerous foodborne outbreaks related to FDA-regulated food products.
        CORE investigations also resulted in numerous public health actions,
        including recalls, public health advisories, Warning Letters, FDA
        prevention strategies, a country-wide Import Alert, and a Consent
        Decree. These are further described in the report.


    --  On Friday, the FDA published its report on new drug approvals in 2023,
        Advancing Health Through Innovation: New Drug Therapy Approvals. This
        report features novel approvals, meaning drugs that have not previously
        been approved in the U.S, along with notable approvals of drugs for new
        and expanded uses, new formulations, and new dosage forms. The report
        also highlights drugs for patients with few or no treatment options,
        including those with rare diseases.
    --  On Friday, the FDA provided updates on the Investigation of Elevated
        Lead Levels in Cinnamon Apple Puree Pouches. In the FDA's testing of the
        recalled products and the cinnamon collected from the Austrofoods
        facility, the agency has found chromium. Due to limitations in available
        testing methods, the FDA was not able to definitively determine the form
        of chromium in the cinnamon apple puree sample (i.e., whether the
        chromium present is chromium (III) or chromium (VI)). The
        lead-to-chromium ratio in the cinnamon apple puree sample is consistent
        with that of lead chromate (PbCrO4) (which contains chromium (VI)), but
        this is not a definitive indicator that lead chromate or chromium (VI)
        (the more toxic form of chromium) was present. People who ate recalled
        products, especially if they had elevated blood lead levels, may have
        been exposed to chromium and should inform their healthcare provider so
        they can monitor health and provide supportive care, as needed.
        Healthcare providers can refer to CDC's Clinician Outreach and
        Communication Activity (COCA Now) announcement for information for
        additional guidance.

Additional Resources:

    --  FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

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. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration