FDA Roundup: May 21, 2024

SILVER SPRING, Md., May 21, 2024 /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 that registration is open for the two-day
        virtual public meeting, "FDA's Fifth Online Controlled Substances
        Summit." The goal of this summit, hosted in partnership with the
        Reagan-Udall Foundation for the FDA, is to identify innovative solutions
        to reduce the illegal availability of controlled substances online. Day
        one of the summit will be a public session with FDA leadership,
        including Commissioner Robert Califf, and other experts that will
        examine the impact and evolution of online purchases of controlled
        substances, as well as review progress that has been made since last
        year's summit. Day two is an invitation-only working session that will
        engage social media, internet, technology and controlled substances
        experts in intensive planning and evaluation to identify immediately
        implementable actions as well as long-term strategies that aim to
        disrupt the trajectory of the current crisis.

    --  Today, the FDA announced it is extending the comment period for the
        proposed rule entitled "Labeling Requirements for Approved or
        Conditionally Approved New Animal Drugs" by 60 days. The agency is
        taking this action in response to a request for an extension to allow
        interested persons additional time to submit comments. Either electronic
        or written comments must be submitted by August 9, 2024.

    --  On Monday, the FDA approved the first two interchangeable biosimilars to
        Eylea (aflibercept), Yesafili (aflibercept-jbvf) and Opuviz
        (aflibercecpt-yszy). Aflibercept products work by inhibiting vascular
        endothelial growth factors (VEGF) and preventing new or abnormal blood
        vessel growth within the eye. By blocking VEGF, these products can help
        to slow down or reduce damage to the retina and preserve vision.
        Additional information about these medications, including their risks
        and side effects, can be found at the CDER notable approval webpage.

    --  On Monday, the FDA published the FDA Voices: "FDA Promotes Clinical
        Trial Innovation," by Hilary Marston, MD, MPH, Chief Medical Officer and
        Kevin Bugin, PhD, Deputy Director of Operations in the Office of New
        Drugs, Center for Drug Evaluation and Research. As the FDA observed
        Clinical Trials Day yesterday, we reflected on the progress made and the
        widespread efforts underway to advance clinical trial innovation. This
        progress has been possible because of clinical trial participants and
        their families, health care professionals, medical product developers,
        federal partners and the entire clinical research community.

    --  On Monday, the FDA announced a public workshop, Evaluating
        Immunosuppressive Effects of In Utero Exposure to Drug and Biologic
        Products. The purpose of the workshop is to discuss transplacental
        transfer of drug and biological products with immunosuppressive
        properties and the potential clinical impact on the developing fetus and
        newborn infant, understand the gaps in knowledge, and consider
        innovative approaches to improve collection of relevant data. The
        workshop will be held July 11 and 12 on-site at FDA's White Oak Campus
        (Silver Spring, MD) and virtually. Registration is required for both
        online and on-site attendance.

    --  On Monday, the FDA Oncology Center of Excellence (OCE) announced the
        formation of The OCE Equity Program. The new program expands Project
        Equity, continuing the OCE's work to improve access to clinical trials
        of oncology medical products for populations that have been historically
        underrepresented in clinical research. The OCE formed Project Equity in
        2021 to focus the OCE's longstanding efforts to address the
        well-documented underrepresentation of racial and ethnic subgroups in
        clinical trials. In addition to racial and ethnic minorities, the OCE
        Equity Program will continue the OCE's efforts to improve trial access
        for individuals who live in rural areas, sexual and gender minorities,
        and individuals with economic, linguistic, or cultural barriers to
        healthcare services.
    --  On Monday, the FDA announced the launch of the Center for Devices and
        Radiological Health and Office of Digital Transformation's precisionFDA
        Phase 1 of the Digitally-Derived Endpoints for Freezing-of-Gait
        Detection Challenge on May 28, 2024. The Challenge seeks artificial
        intelligence (AI) models to identify and predict digitally-derived
        endpoints for freezing of gait events related to Parkinson's disease.
        Medical device developers, tech innovators, software developers, and
        academic researchers are invited to participate. Register to participate
        in the challenge today and submit AI models before August 2, 2024.

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