OMHHE Enhance Equity Research Hub - Spotlight
The FDA Office of Minority Health and Health Equity (OMHHE) Enhance Equity Research Hub is a searchable repository that provides information about OMHHE-funded research projects.
This week, we spotlight the work of researchers Wei Sun, PhD; Monica Ponder, PhD; Shoaa Almalki, PhD; and Donna Oti, PhD who worked on a project titled, “Bridging Gaps: Recruiting African and Asian American Participants in Clinical Trials and Creating Culturally Competent Messages.” The study goal was to increase understanding of knowledge and attitudes toward clinical trial participation and communication preferences of Asian and Black or African American populations.
News At FDA
FDA Clears First Device to Enable Automated Insulin Dosing for Individuals with Type 2 Diabetes
The FDA expanded the indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes in individuals two years and older, to also include management of type 2 diabetes in individuals 18 years and older.
FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
The FDA approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. The actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.
FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis
The FDA granted marketing authorization to NOWDiagnostics for the First To Know Syphilis Test. This is the first at-home, over-the-counter test to detect Treponema pallidum (syphilis) antibodies in human blood.
FDA Issues Warning Letter to Austrofood and Continues Robust Activities to Ensure Safety of Cinnamon Products Sold in U.S.
Last fall, the FDA and regulatory health partners initiated an investigation of apple cinnamon fruit puree pouches that were recalled after they were found to be contaminated with harmful levels of lead and chromium.
FDA Announces Milestone in Sodium Reduction Efforts, Issues Draft Guidance with Lower Target Levels for Certain Foods
The FDA marked a milestone building on Phase I of its voluntary sodium reduction targets and issued draft guidance for Phase II in a data-driven, stepwise approach to help sodium reduction across the food supply.
Voices in Health Equity
Language Access: A Source for Better Health
By: The Language Access Affinity Group, HHS Office of Minority Health
Language barriers experienced by people with limited English proficiency (LEP) can lead to disparities in health care access and health outcomes. The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) is joining agencies across the federal government in the release of a 2024-2026 Language Access Plan (LAP).
Upcoming Events
FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA
September 4, 11:00 a.m. - 3:00 p.m. ET, Virtual
This webinar hosted by the FDA Center for Drug Evaluation and Research aims to educate early-stage companies (small businesses) new to the regulatory landscape at the FDA.
ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients
September 6, 9:00 a.m. - 5:00 p.m. ET, Virtual and In-person
The FDA in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (MCERSI) is convening this one-day workshop to solicit input from stakeholders on increasing the enrollment of historically underrepresented populations in pediatric clinical studies, and encouraging pediatric clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups.
Framework for Understanding Structural Ableism in Health Care
September 9, 2:00 p.m. - 3:30 p.m. ET, Virtual
The Office for Disparities Research and Workforce Diversity at the National Institute of Mental Health is hosting a webinar which will introduce a conceptual framework outlining pathways through which structural ableism in public health and health care may contribute to health inequities for people who are disabled, neurodivergent, chronically ill, mad, and/or living with mental illness.
FDA Omics Days 2024 - Precision in Practice: Regulatory Science, Best Practices, and Future Directions in Omics
September 12, 9:00 a.m. - 4:30 p.m. ET, Virtual and In-person
For this virtual and in-person event, the FDA Omics Working Group will be hosting speakers from industry, academia, and government to discuss topics important to the FDA. This event will include sessions on contemporary topics in the fields of precision medicine, multi-omics, and One Health.
FDA Grand Rounds - Advancing blood safety and patient health in HIV/AIDS through FDA’s research on viral genome surveillance, diagnostic technologies, and biomarker discovery
September 12, 12:00 p.m. - 1:00 p.m. ET, Virtual
This virtual presentation will focus on FDA’s regulatory research efforts to advance effectiveness of testing through development of standards, evaluation of novel detection methodologies to improve virus detection and, identification of biomarkers for latency in the context of Pre-Exposure Prophylaxis (PrEP) and Anti-retroviral therapy (ART) which have been widely implemented.
FDA Oncology Center of Excellence Presents: Conversations on Cancer: National Hispanic Family Cancer Awareness Week
September 20, 11:00 a.m. - 12:00 p.m. ET, Virtual
This panel discussion is part of National Hispanic Family Cancer Awareness Week, which aims to gather community-based groups to increase cancer awareness and build knowledge surrounding cancer clinical trial participation as well as increasing understanding of ways to contribute to national genetic databases for cancer research.
Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases
September 20, 11:00 a.m. - 4:30 p.m. ET, Virtual
The FDA Center for Biologics Evaluation and Research (CBER) is hosting the first of two virtual patient listening meetings to better understand patient and care partner perspectives on safety considerations and long-term follow-up for approved gene therapy treatments for rare diseases. Register now:
In Case You Missed It
Advancing Clinical Trial Participation for the LGBTQIA+ Community
By: Christine Lee, Acting Associate Commissioner for Minority Health, Office of Minority Health and Health Equity
Representatives of the FDA were fortunate to attend a community discussion on advancing clinical trial diversity for sexual and gender minority communities to help improve the generalizability of trial results across the entire population of patients who may use medical products.
It’s a Good Time to Get Your Flu Vaccine
Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated in the fall can lower your chances of getting the flu.
Skip the Antibacterial Soap; Use Plain Soap and Water
There isn’t evidence to show that over-the-counter (OTC) antibacterial soaps are better at preventing illness than washing with plain soap and water. In fact, some data suggest that antibacterial ingredients could do more harm than good over the long-term.
Eating Too Much Salt? Ways to Cut Back...Gradually
Reducing your salt intake is one way to improve your health. Here are four steps to help you cut back gradually.
Resources For You
OMHHE offers many easy-to-use and culturally-appropriate resources on minority health, health disparities, and related topics. These resources are available to view online, print, or share. Some are available in Spanish and additional languages.
Visit www.fda.gov/HealthEquityResources for more information.
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