FDA Roundup: March 28, 2025

SILVER SPRING, Md., March 28, 2025 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

    --  On Thursday, the FDA's Learning and Education to ADvance and Empower
        Rare Disease Drug Developers initiative published two new videos titled
        "Understanding the Importance of Endpoints in Rare Disease Drug
        Development" and "Considerations for Collecting and Using Natural
        History Study Data that are Fit for Use in the Regulatory Setting" to
        our educational video series. The videos provide an overview of
        important considerations for selecting endpoints when designing clinical
        trials, and concepts to consider when determining how to leverage
        natural history study data to support regulatory decision making on a
        marketing application.


    --  On Wednesday, the FDA issued a Blue Box update to a Safety Alert on
        contaminated Korean oysters, adding additional recalled products.


    --  On Wednesday, the FDA celebrated 15 years since the passage of the
        Biologics Price Competition and Innovation Act (BPCIA). The BPCI Act
        created an abbreviated approval pathway to help provide patients with
        greater access to safe and effective biological products, and it
        established a framework to promote both innovation and competition. This
        year also marks the 10(th) anniversary since the approval of the first
        biosimilar in the United States. The FDA has approved 69 biosimilars
        since 2015. More information can be found at the CDER Conversation.


    --  On Wednesday, the FDA approved Exelixis, Inc.'s Cabometyx (cabozantinib)
        for adult and pediatric patients 12 years of age and older with
        previously treated, unresectable, locally advanced or metastatic,
        well-differentiated pancreatic neuroendocrine tumors and for adult and
        pediatric patients 12 years of age and older with previously treated,
        unresectable, locally advanced or metastatic, well-differentiated
        extra-pancreatic neuroendocrine tumors. More information about Cabometyx
        can be found in the full prescribing information.


    --  On Wednesday, the FDA published the Pulse Oximeter Basics Consumer
        Update. Consumers are increasingly using pulse oximeters in-home when
        they are not feeling well or to monitor their general health. The FDA
        wants to help consumers breathe easy and know how these devices can be
        used safely and accurately.


    --  On Wednesday, the FDA provided an update from our ongoing postmarket
        evaluation of Essure by posting information on medical device reports
        received by the FDA related to Essure during the 2024 calendar year.
        Although Essure, a permanently implanted birth control device for women,
        has not been available for implantation since December 2019, the FDA
        remains committed to collecting and providing updates on the long-term
        safety information about Essure.
    --  On Tuesday, the FDA posted a web page celebrating the 100-year
        anniversary of the National Seafood Sanitation Program (NSSP). The NSSP
        is a partnership between certain states and federal agencies to prevent
        contaminated shellfish from entering the market. This program helps to
        ensure that bivalve molluscan shellfish (including oysters, clams,
        mussels, cockles, and scallops, other than adductor only) sold in the
        United States are safely produced and sold to consumers. The NSSP was
        established after a widespread deadly typhoid fever outbreak was traced
        to contaminated oysters in 1924.

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