January 7, 2025 - FDA Roundup: January 7, 2025

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  In June 2024, the FDA published the draft guidance, "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies."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.

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