FDA Roundup: January 17, 2025

SILVER SPRING, Md., Jan. 17, 2025 /PRNewswire/ -- 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 release of a new prevention strategy aimed
        at combating the contamination of fresh and frozen berries with enteric
        viruses, such as Hepatitis A Virus and Norovirus. This strategy outlines
        a series of actions designed to enhance communication, implement
        consistent prevention measures globally, and fill significant research
        gaps in the detection and management of these enteric viruses. Key
        components include fostering scientific research to understand enteric
        viruses' behaviors in various environments and enhancing surveillance
        efforts that have been ongoing since FY19 to FY23. This comprehensive
        approach underscores the FDA's commitment to reducing foodborne
        illnesses linked to berry consumption through collaborative efforts with
        industry interest holders and global partners. For more information, the
        FDA encourages visiting Prevention Strategies to Enhance Food Safety or
        contacting FoodSafetyPreventionStrategies@fda.hhs.gov.




    --  Today, the FDA issued a notice in the Federal Register announcing a
        virtual public workshop entitled "Cell Therapies and Tissue-Based
        Products: A Public Workshop on Generating Scientific Evidence to
        Facilitate Development." The purpose of this workshop is to discuss the
        current state of the science for development and testing of certain
        cellular therapies and tissue-based products. In particular, the FDA is
        convening this public workshop with relevant stakeholders to discuss
        best practices on generating scientific data necessary to further
        facilitate the development of cellular therapies, including stem cell
        products.  The public workshop will be held virtually on February 25,
        2025, from 8:30 a.m. - 5:00 p.m. Eastern Time. Registration by 8:30 a.m.
        on February 25, 2025, is required. Those interested can submit
        electronic or written comments on this public workshop utilizing the
        process provided in the Federal Register. Additional information about
        this workshop is available on FDA's website.




    --  Today, the FDA released the IT Operating Plan for Fiscal Years 2024 -
        2027, which provides the agency's strategic blueprint for technology and
        data in support of advancing public health. The plan incorporates
        ongoing collaboration with the FDA's executive committees and advisory
        boards to ensure these efforts continue to align with the FDA mission
        and IT and data goals. The plan also emphasizes increased global
        collaboration to strengthen public health response, leveraging emerging
        technologies like artificial intelligence, enhancing data sharing and
        developing and maintaining advanced cybersecurity practices. The plan
        was developed with input through workshops, listening sessions and a
        Federal Register Notice. By modernizing IT capabilities, optimizing
        investments and creating a unified "OneFDA" digital ecosystem, the
        agency enhances its efficiency, improves stakeholder experiences and
        best supports innovation in public health.




    --  On Thursday, the FDA announced a public workshop, Optimizing Pregnancy
        Registries. The purpose of the workshop is to discuss challenges in
        designing and implementing pregnancy registries and consider innovative
        approaches to improve the design and conduct of pregnancy registries to
        inform the safety of drug and biological products during pregnancy.  
        The workshop will be held March 27 - 28, 2025, on-site at the FDA's
        White Oak Campus and virtually. Registration is required.


    --  Today, the FDA issued the Center for Devices and Radiological Health
        (CDRH) 2024 Annual Report. The report illustrates the many ways CDRH
        continues to advance safe, effective, and high-quality medical devices,
        and safe radiation-emitting products. CDRH took significant actions to
        protect and promote the public health and improve device safety, while
        fostering the development of medical devices that address unmet needs
        and provide a significant benefit to patients in the U.S.






    --  On Thursday, the FDA issued a statement on medical device supply chain
        vulnerabilities, the public health impact they have on patient care, the
        FDA's actions to prevent and mitigate potential shortages, and solutions
        to strengthen the domestic supply chain and address these
        vulnerabilities. "A critical focus of the FDA is preventing and
        mitigating potential medical device shortages. From ventilators and
        neonatal breathing tubes to hemodialysis catheters, the scarcity of
        these critical devices poses a growing threat to patient care -
        especially for our youngest and most vulnerable populations. While the
        vulnerabilities in the medical device supply chain are not new, we are
        growing increasingly concerned that the rise in shortages is having a
        significant adverse impact on neonatal and pediatric patients," said
        Michelle Tarver, M.D., Ph.D., director of the Center for Devices and
        Radiological Health.The FDA is interested in hearing from health care
        facilities and providers that may be having difficulty obtaining medical
        devices, as well as from other interested parties who may be impacted by
        potential shortages. Please email the FDA at
        deviceshortages@fda.hhs.gov.


    --  On Thursday, the FDA announced an early alert about Fresenius Kabi USA
        recommending certain software versions of the Ivenix Infusion System be
        updated related to a potentially high-risk device issue. The company
        reported two anomalies associated with software versions 5.9.2 and
        earlier. These anomalies have the potential to cause serious patient
        harm or death, including patients being underdosed or over infused.


    --  On Thursday, the FDA approved Lumakras (sotorasib) with Vectibix
        (panitumumab) for adult patients with KRAS G12C-mutated metastatic
        colorectal cancer (mCRC), as determined by an FDA-approved test, who
        have received prior fluoropyrimidine-, oxaliplatin-, and
        irinotecan-based chemotherapy. The FDA also approved the therascreen
        KRAS RGQ PCR Kit (QIAGEN GmbH) as a companion diagnostic device to aid
        in identifying patients with colorectal cancer whose tumors harbor KRAS
        G12C mutations and who may be eligible for Lumakras with Vectibix. The
        most common adverse reactions (>=20%) for sotorasib 960 mg/panitumumab
        were rash, dry skin, diarrhea, stomatitis, fatigue, and musculoskeletal
        pain. The most common Grade 3-4 laboratory abnormalities in >= 2
        patients were decreased magnesium, decreased potassium, decreased
        corrected calcium, and increased potassium.


    --  On Thursday, the FDA granted traditional approval to Calquence
        (acalabrutinib) with bendamustine and rituximab for adults with
        previously untreated mantle cell lymphoma (MCL) who are ineligible for
        autologous hematopoietic stem cell transplantation (HSCT). FDA also
        granted traditional approval to acalabrutinib as a single agent for
        adults with previously treated MCL. Acalabrutinib received accelerated
        approval for this indication in 2017. Serious adverse reactions occurred
        in 69% of patients with acalabrutinib plus BR, and fatal adverse
        reactions occurred in 12%. Serious adverse reactions reported in >=2% of
        patients were pneumonia, COVID-19, pyrexia, second primary malignancy,
        rash, febrile neutropenia, atrial fibrillation, sepsis, and anemia.




    --  On Wednesday, the FDA issued an order to revoke the authorization for
        the use of FD&C Red No. 3 in food and ingested drugs in response to a
        2022 color additive petition that requested the agency to review whether
        the Delaney Clause applied."The FDA is taking action that will remove
        the authorization for the use of FD&C Red No. 3 in food and ingested
        drugs. The Delaney Clause is clear; the FDA cannot authorize a food
        additive or color additive if it has been found to cause cancer in
        humans or animals. Evidence shows cancer in laboratory male rats exposed
        to high levels of FD&C Red No.3. Importantly, the way that FD&C Red No.
        3 causes cancer in male rats does not occur in humans," says Jim Jones,
        Deputy Commissioner for Human Foods.


    --  On Wednesday, the FDA requested comments about the FDA's Digital Health
        Advisory Committee discussion during the meeting in November 2024
        related to Total Product Lifecycle Considerations for Generative
        Artificial Intelligence-Enabled Medical Devices. Please submit comments
        to docket FDA-2024-3924 on or before January 21, 2025. Note that late,
        untimely filed comments will not be considered.


    --  On Wednesday, the FDA's Center for Veterinary Medicine released a
        request for information (RFI) soliciting comments from the public,
        particularly veterinarians, related to the use of cannabis-derived
        products (CDP) in animals. Information received through this RFI will
        enhance the FDA's knowledge of potential safety signals associated with
        CDPs and improve the FDA's understanding of veterinarians' experiences
        related to the use of CDPs in their animal patients. The Federal
        Register Notice about the RFI contains instructions for submitting
        comments. The FDA will fully consider all comments, including comments
        submitted anonymously. The comment period for this RFI will be open for
        90 days, ending on April 16, 2025.
    --  On Wednesday, the FDA's Rare Disease Innovation Hub (the Hub) released
        its Strategic Agenda, which outlines the actions the Hub plans to
        undertake during its first year with extensive involvement from the rare
        disease community, while also addressing questions about the ultimate
        structure and programs of the Hub.  The Strategic Agenda reflects
        extensive input from and partnership with the larger rare disease
        community, and identifies the following goals for the Hub:
        --  Goal 1 - Further Advance Regulatory Science of Rare Disease
            Therapies
        --  Goal 2 - Enhance and Strengthen Coordination and Alignment Between
            FDA's Medical Product Centers, with Particular Focus on the Center
            for Biologics Evaluation and Research (CBER) and the Center for Drug
            Evaluation and Research (CDER)
        --  Goal 3 - Create a Centralized Point of Contact for External Partners

The Strategic Agenda is available on FDA's website.

    --  On Tuesday the FDA published the Animal Welfare, Testing and Research of
        FDA-Regulated Products Consumer Update. Medical and veterinary products
        save lives every day. The FDA-regulated products undergo different types
        of testing to determine their safety and effectiveness. These tests may
        include animal testing, and they almost always include other types of
        tests. The FDA encourages and accepts scientifically valid alternatives
        to animal testing.


    --  On Tuesday, the FDA issued a Request for Information (RFI) on
        manufacturing processes and ingredients used to make certain dairy
        products which, for purposes of the RFI, we refer to as high-protein
        yogurt, Greek yogurt, or Greek-style yogurt (also collectively referred
        to as "high-protein yogurt" in this RFI). These dairy products are
        cultured with, at minimum, Lactobacillus delbrueckii, subspecies
        bulgaricus, and Streptococcus thermophilus. The FDA is taking this
        action, in part, because the existing yogurt standard of identity (SOI)
        may not align with certain manufacturing processes and ingredients used
        to concentrate protein to manufacture high-protein yogurt.
    --  On Monday, the FDA published a Spotlight on CDER Science featuring
        CDER's work with international regulators to develop a methodology, the
        Carcinogenic Potency Categorization Approach (CPCA), that uses the
        chemical structure of a nitrosamine impurity to recommend acceptable
        intake (AI) limits by assignment to 1 of 5 predicted potency categories
        reflecting carcinogenic risk. The application of the CPCA to determine
        recommended AI limits for nitrosamine impurities has expedited the
        regulatory review of drug safety assessments submitted by drug companies
        as an AI limit can be identified more efficiently and with greater
        transparency and predictability.

Additional Resources:

    --  FDA Newsroom

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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