FDA Roundup: January 7, 2025

SILVER SPRING, Md., Jan. 7, 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 posted warning letters sent to six firms selling
        unapproved drugs that claim to treat and control seizures in dogs and
        cats. The companies that received warning letters include Nutrition
        Strength Ltd. EOOD, Evolution Pets, Doc Ackerman's Pet Products,
        Energetic Essences, LLC dba Pet Essences, HD Frenchies, LLC/Bully Baum,
        and Vet Select Formula, Inc. Anyone currently administering the
        unapproved animal drugs mentioned in these warning letters should
        consult a licensed veterinarian to obtain an accurate diagnosis and
        appropriate treatment. If you have been giving these products to your
        pets, safely dispose of them. Pet owners and veterinarians are
        encouraged to report animal adverse events to the FDA's Center for
        Veterinary Medicine: How to Report Animal Drug and Device Side Effects
        and Product Problems.


    --  On Monday, the FDA and the National Institutes of Health (NIH) announced
        that registration is open for the FDA-NIH Rare Disease Day 2025 meeting.
        This free, two-day public event will be held on February 27 and 28,
        2025, on the NIH main campus at the Natcher Conference Center in
        Bethesda, Maryland, and virtually. This Rare Disease Day event aims to
        raise awareness about rare diseases, the people they affect, and NIH and
        FDA collaborations that address scientific challenges and advance
        research for new treatments. The meeting will feature panel discussions,
        rare diseases stories, in-person exhibitors and scientific posters, and
        an art exhibition. We invite patients, advocates, caregivers, health
        care providers, researchers, trainees, students, industry
        representatives, and government staff who are committed to highlighting
        patient voices and advancing scientific discoveries for rare diseases to
        learn more and register.


    --  On Friday, the FDA submitted its report to Congress, "Diversity Action
        Plans Summary:  FY 2023 and FY 2024," which summarizes the diversity
        plans the agency received during that timeframe. The Food and Drug
        Omnibus Reform Act of 2022 (FDORA) requires the FDA to submit this
        summary annually to Congress and post it on the agency's public
        website.In June 2024, the FDA published the draft guidance, "Diversity
        Action Plans to Improve Enrollment of Participants from Underrepresented
        Populations in Clinical Studies." The requirement to submit Diversity
        Action Plans will apply to certain studies for which enrollment begins
        after 180 days from the publication of the final guidance. However, the
        agency is publishing this report now to highlight that certain sponsors
        have already initiated the process of preparing and submitting voluntary
        diversity plans for some clinical studies.

This week, the FDA issued several guidances that lay out the agency's current thinking and advice to industry on important topics. Links and details about a number of guidances are included below:

    --  Today, the FDA issued a draft guidance, "Evaluation of Sex-Specific and
        Gender-Specific Data in Medical Device Clinical Studies". The draft
        guidance encourages science-driven consideration of sex and/or gender,
        as appropriate for both the scientific question being addressed and the
        intended use of the device, when designing medical device clinical
        studies and reporting data from such studies in accordance with legal
        requirements. Upon finalization, this document will update the policy
        reflected in the existing 2014 guidance, "Evaluation of Sex-Specific
        Data in Medical Device Clinical Studies" by addressing both sex- and
        gender-specific data and will replace the existing guidance.. This draft
        guidance is not for implementation at this time. The FDA will consider
        comments on this draft guidance before it begins work on the final
        version of the guidance. Submit comments under docket number
        FDA-2023-D-5591 at
        https://www.federalregister.gov/agencies/food-and-drug-administration by
        April 7, 2025, to ensure the FDA considers comments on this draft
        guidance before it begins work on the final version.


    --  Today, the FDA issued a draft guidance, "Developing Drugs for Optical
        Imaging." This guidance provides recommendations to drug companies on
        the design of clinical trials for optical imaging drugs used with
        imaging devices during surgery to detect tumors or other pathology or to
        delineate normal anatomical structures.




    --  On Monday, the FDA issued a final guidance, "Guidance for Industry:
        Action Levels for Lead in Processed Food Intended for Babies and Young
        Children." The guidance supports our Closer to Zero initiative to reduce
        dietary exposure to contaminants, including lead, in foods to as low as
        possible over time, while maintaining access to nutritious foods. "The
        FDA's guidance for industry is a major step in our commitment to driving
        down dietary exposure to contaminants like lead in foods intended for
        babies and young children to as low as possible while maintaining access
        to nutritious food," said FDA Deputy Commissioner for Human Foods Jim
        Jones. "We are confident that the action levels outlined in the
        guidance, along with our continued work with federal partners, industry,
        and consumer and health advocacy groups, will result in sustainable
        reductions in dietary exposure to lead from processed foods."


    --  On Monday, the FDA issued a final guidance, "Guidance for Industry (GFI)
        #294: Animal Food Ingredient Consultation (AFIC)". The FDA intends to
        conduct voluntary consultations with firms developing animal food
        ingredients through the Animal Food Ingredient Consultation (AFIC)
        process described in GFI #294 while the agency conducts an evaluation of
        its animal Food Additive Petition (FAP) and Generally Recognized As Safe
        (GRAS) Notification programs. For example, the AFIC process could be
        used by firms with animal food ingredients that may have otherwise gone
        through the Association of American Feed Control Officials (AAFCO)
        ingredient definition process before the October 2024 expiration of the
        FDA-AAFCO MOU.


    --  On Monday, the FDA issued a draft guidance, "Accelerated Approval and
        Considerations for Determining Whether a Confirmatory Trial is
        Underway". For drugs granted accelerated approval, sponsors conduct
        confirmatory studies that must be completed post approval to verify and
        describe the anticipated effect on irreversible morbidity or mortality
        or other clinical benefit. This draft guidance describes the FDA's
        interpretation of the term "underway" and discusses policies for
        implementing this requirement, including factors the FDA intends to
        consider when determining whether a confirmatory trial is underway prior
        to accelerated approval.


    --  On Monday, the FDA issued a draft guidance, "Study of Sex Differences in
        the Clinical Evaluation of Medical Products". Differences in physiology
        between females and males can lead to differences in disease
        manifestation, pharmacokinetics, pharmacodynamics, and response to
        treatment. Analyzing sex-related differences in medical product response
        is an important component of assessing product safety and effectiveness
        and can inform what goes into product labeling. This guidance provides
        recommendations for increasing enrollment of females in clinical trials,
        analyzing and interpreting sex-specific data, and including sex-specific
        information in regulatory submissions of medical products.




    --  On Monday, the FDA issued a draft guidance with the Office for Human
        Research Protections, "Considerations for Including Tissue Biopsies in
        Clinical Trials." The draft guidance is intended, when finalized, to
        assist industry, clinical investigators, institutions, and institutional
        review boards in understanding considerations for tissue biopsies in
        adults and children as part of clinical trials that evaluate
        investigational medical products and/or that are conducted or supported
        by the U.S. Department of Health and Human Services (HHS)."Tissue
        biopsies in clinical trials are often needed to determine eligibility or
        to understand the effect of the medical product being studied in the
        trial," said Richard Pazdur, M.D., director of the FDA's Oncology Center
        of Excellence and acting director of the Office of Oncologic Diseases in
        the FDA's Center for Drug Evaluation and Research. "This new draft
        guidance builds on the agency's ongoing efforts to enhance clinical
        trials by providing recommendations to improve participant safety and
        further clinical research."




    --  On Monday, the FDA issued four draft guidances and two final guidances
        on human cells, tissues, and cellular and tissue-based products (HCT/Ps)
        regarding donor eligibility determinations. The guidances, including the
        draft guidances when finalized, are intended to provide recommendations
        to establishments that make donor eligibility determinations and update
        existing FDA guidance on a number of related topics."The FDA continues
        to work diligently to ensure that HCT/P donor-eligibility
        recommendations are grounded in the best available science and data,"
        said Peter Marks, M.D., Ph.D., director of the FDA's Center for
        Biologics Evaluation and Research (CBER). "Following these
        recommendations may result in an expanded pool of eligible donors, while
        also maintaining appropriate safeguards. We remain committed to
        following the best available scientific evidence to help minimize the
        risk of transmitting infectious diseases through these products."The
        guidances on donor eligibility determinations published this week
        include:

-- Recommendations for Determining Donor Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): This draft guidance is a general guidance intended to assist establishments in understanding the requirements for determining eligibility, including donor screening and testing. -- Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); and Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products(HCT/Ps): These three draft guidances provide updated recommendations to reduce the risk of HIV, HBV, and HCV transmission, and include several updates to our existing recommendations, including the following: -- Revising recommendations for donor screening that includes reducing certain time-based risk factors and conditions; and -- Eliminating the HCT/P donor screening questions specific to men who have sex with men (MSM) and women who have sex with MSM and, instead recommending that establishments assess HCT/P donor eligibility using the same individual risk-based questions relevant to HIV, HBV, and HCV risk for every donor regardless of sex or gender. -- Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); and Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): These final guidances are intended for immediate implementation, and provide recommendations to assist establishments in complying with certain regulatory requirements for donor eligibility determinations to reduce the risk of transmission of Mtb or infections due to sepsis.

    --  On Monday, the FDA issued a final guidance, "Notifying FDA of a
        Permanent Discontinuance or Interruption in Manufacturing of a Device
        Under Section 506J of the FD&C Act". Under section 506J of the FD&C Act,
        manufacturers are required to notify the FDA, during or in advance of a
        public health emergency, of a permanent discontinuance or interruption
        in the manufacturing of certain devices that is likely to lead to a
        meaningful disruption in supply of that device in the United States.
        This guidance provides information about notifications under section
        506J during or in advance of any public health emergency. On Tuesday,
        March 4, 2025, the FDA will host a webinar for those interested in
        learning more about the guidance.

Additional Resources:

    --  FDA Newsroom

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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