 National Minority Mental Health Awareness Month
July is National Minority Mental Health Awareness Month, a time to bring attention to the unique challenges that racial and ethnic minority groups in the U.S. face when it comes to mental illness. The FDA Office of Minority Health and Health Equity (OMHHE) has added two new fact sheets to our Minority Health and Health Equity Resources about anxiety and depression. Click the buttons below to learn more about these common mental illnesses or to share the new fact sheets with friends, family, or loved ones.
News At FDA
FDA Guidance Provides New Details on Diversity Action Plans Required for Certain Clinical Studies
The FDA issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product.
OMHHE Enhance Equity Research Hub
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.
The Enhance Equity Research Hub is part of the Enhance Equity Initiative and part of OMHHE's efforts to support our mission to promote and protect the health of diverse populations through research and communication of science that addresses health disparities.
Home as a Health Care Hub
The FDA announced a new web page for the Home as a Health Care Hub initiative, which offers more detail about the initiative’s goals and background, answers frequently asked questions, and it’s where the FDA will share progress.
FDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products After Extensive Scientific Review
Following an extensive scientific review, the FDA authorized the marketing of four e-cigarette products in the United States through the premarket tobacco product application (PMTA) pathway.
FDA Expands Approval of Gene Therapy for Patients with Duchenne Muscular Dystrophy
The FDA expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD) for ambulatory and non-ambulatory individuals 4 years of age and older with DMD with a confirmed mutation in the DMD gene.
Voices in Health Equity
Blog: The Promise Artificial Intelligence Holds for Improving Health Care
By: Troy Tazbaz, Director, Digital Health Center of Excellence (DHCoE), Center for Devices and Radiological Health, U.S. Food and Drug Administration
Artificial intelligence (AI) is rapidly changing the health care industry and holds transformative potential. At the FDA, we know that the proper integration of AI across the health care ecosystem will be important to achieving its potential while reducing risks and challenges.
Evolving Perspectives on Healthcare Algorithmic and Artificial Intelligence Bias
By Caleb J. Colón-Rodríguez, DrPH, MHSA, Public Health Analyst, Division of Program Operations, Office of Minority Health, U.S. Department of Health and Human Services
This blog post from the HHS Office of Minority Health (OMH) explores the use of AI in healthcare and how experts are working to set the ground rules for healthcare technology.
Upcoming Events
FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Exploring Religious Literacy and Spirituality in Cancer Care”
July 10, 2:00 p.m. - 3:30 p.m. ET, Virtual
Join the FDA Oncology Center of Excellence for a public panel discussion on the role of religious literacy and spirituality in cancer care.
Salmonella and Escherichia coli: Challenges Along the One Health Continuum
July 11, 12:00 p.m. - 1:00 p.m. ET, Virtual
The presentation will focus on Salmonella and Escherichia coli which are bacterial pathogens that infects humans and a wide range of other animal hosts where they have the potential to spread to across species. Many of these strains are also resistant to multiple antibiotics which leads to increased treatment challenges, making this antimicrobial resistance a significant public health concern.
Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products
July 11, 9:00 a.m. - 5:00 p.m. ET; July 12, 9:00 a.m. - 1:00 p.m. ET; Virtual and In-person
This public workshop will 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.
Introduction to FDA’s Office of Trade and Global Partnerships
July 23, 1:00 p.m. - 2:00 p.m. ET, Virtual
This webinar will introduce FDA’s Office of Trade and Global Partnerships (OTGP). OTGP serves as the FDA lead for addressing issues related to international trade of regulated products, mutual recognition agreements, and entering into arrangements and sharing information with global counterparts.
Online Controlled Substances Summit
July 25, 11 a.m. - 3 p.m. ET; Virtual
The FDA, in partnership with the Reagan-Udall Foundation for the FDA, is hosting a virtual public session where FDA leadership, including Commissioner Dr. Robert Califf and other experts, will examine the impact and evolution of online purchases of controlled substances.
Home as a Health Care Hub – Stakeholder Listening Session
July 25, 12:00 p.m. - 4:00 p.m. ET, Virtual
This FDA is announcing a virtual public meeting where participants will discuss the home environment as an integral part of the health care system and share information about FDA’s newly launched Home as a Health Care Hub initiative. During the meeting, the FDA will solicit input from stakeholders to inform future direction of the Home as a Health Care Hub initiative, and create a dialogue on the barriers and opportunities for the delivery of health care and the generation of clinical evidence in the home environment.
Opportunities
Development of Public Health Vaccine and Prevention Educational Campaigns Involving Community Health Workers
The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) seeks input on involving community health workers to increase “cultural competency in educational campaigns on public health vaccines and prevention, including but not limited to influenza and COVID-19.”
The deadline for submitting comments is July 11, 2024.
Funding Opportunity Announcement: Animal and Veterinary Innovation Centers
This effort is part of the FDA’s ongoing commitment to encourage development of innovative products to better support animal health and veterinary interventions, including those that prevent, control, or eliminate Highly Pathogenic Avian Influenza virus in animals, or interventions that reduce the circulation of the virus in the ecosystem.
In Case You Missed It
Get Tested for HIV
FDA-approved HIV prevention and treatment options are available. The first step is getting tested.
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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