 Asian American, Native Hawaiian and Pacific Islander Heritage Month
This May, as the Office of Minority Health and Health Equity (OMHHE) celebrates Asian American, Native Hawaiian, and Pacific Islander Heritage Month, we invite you to listen to the newest episode of the Health Equity Forum podcast, “Engaging Native Hawaiian Communities in Clinical Trials.” In this episode, OMHHE Acting Director Dr. Christine Lee speaks with Dr. Todd Seto and Dr. Deb Taira of the Queen’s Medical Center on their research with the Hawaii Health Equity Research and Outreach Network (Hawaii HERON). Drs. Seto and Taira’s work with Hawaii HERON aims to address and reduce health disparities experienced by Asian American, Native Hawaiian, and Pacific Islander communities.
News At FDA
FDA Clarifies Approach to Genomic Alterations in Animals
The FDA took important steps to advance the FDA’s regulatory process for intentional genomic alterations (IGAs) in animals. The updated guidance documents underscore the agency’s commitment to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products to increase regulatory flexibility, predictability and efficiency.
FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests
The FDA took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years.
FDA to Hold Listening Session as Part of Broader Work to Optimize Use of, and Processes for, Advisory Committees
The FDA announced it will host a listening session in June as part of its broader work to optimize the use of, and processes for, advisory committees. This virtual public meeting will focus on the composition of advisory committees, ways to improve the experience for members serving on committees and ways to ensure public awareness and understanding of the role of FDA advisory committees.
FDA Approves New Treatment for Uncomplicated Urinary Tract Infections
The FDA approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
FDA establishes CDER Center for Clinical Trial Innovation (C3TI)
The FDA's Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally.
Voices in Health Equity
A Milestone in Facilitating the Development of Safe and Effective Biosimilars
By: Sarah Yim, M.D., Director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, Hilary Marston, M.D., M.P.H., Chief Medical Officer and Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research
Biologics are some of the most expensive treatments in the U.S., and approving biosimilars can enhance competition, drive down costs to health care systems, and increase patient access to biologic therapies.
Reflections on Travel to Europe – Part Two
By: Robert M. Califf, M.D., Commissioner of Food and Drugs
In part two of a three-part series of blogs, Dr. Califf provides his perspective on his recent trip to Europe and describes key events and issues. The team’s official travel took them to the U.K. for an initial dinner with an eclectic group from the nation, dealing with policies ranging from women’s health and diversity in clinical trials to the impact of the medical products industry on the economy to pandemic preparedness and response.
Reflections on Travel to Europe – Part Three
By: Robert M. Califf, M.D., Commissioner of Food and Drugs
In this final of a three-part series of blogs, the team’s official travel took them for visits with the U.S. Mission to the European Union (EU) in Brussels; Ambassador Gitenstein, the U.S. Ambassador to the EU; the European Food Safety Authority; the European Commission and the Directorate-General SANTE; and the European Medicines Agency.
Upcoming Events
Public Workshop: In-person and Hybrid How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases
May 9, 9:00 a.m. - 4:00 p.m. ET, Virtual and In-person
This one-day public workshop aims to provide an interdisciplinary forum to discuss the best practices of trial design, analyses, and interpretation of trials with multiple phases of treatment.
FDA Grand Rounds: Whole Genome Sequencing: A Powerful Scientific Tool that Delivered During the 2023 Pseudomonas Outbreak in Eye Drops
May 9, 12:00 p.m. - 1:00 p.m. ET, Virtual
Whole Genome Sequencing has been used in FDA’s Human and Animal Food Laboratories for several years, but what about in the medical products laboratories? This presentation will discuss the application of this method as an additional analysis used during the 2023 Pseudomonas outbreak in eye drop products.
Improving the Diagnosis and Treatment of Women with Myocardial Ischemia and Non-obstructive Coronary Arteries
May 9, 3:00 p.m. – 4:00 p.m. ET, Virtual
Ischemic heart disease is a leading cause of morbidity and mortality in women. This presentation will review the causes of ischemic heart disease in women, challenges with current symptom assessment measures, and propose a new path for better diagnosis and treatment of heart disease in women.
Collaborating on Culture in the New Era of Smarter Food Safety
May 9, 5:15 PM - 6:30 PM ET, Virtual
The FDA will host the final webinar in the series, Collaborating on Culture in the New Era of Smarter Food Safety. The webinar series exploring food safety culture is in partnership with Stop Foodborne Illness, a non-profit public health organization. The series facilitates a collaborative dialogue among experts from both public and private sectors and explores the significance of fostering a strong food safety culture to ensure the production of safe food.
Osteoporosis: A Perspective for 2024
May 16, 12:00 p.m. - 1:00 p.m. ET, Virtual
In observance of National Women's Health Week 2024 and National Osteoporosis Awareness and Prevention month, the FDA Office of Women’s Health will host a free virtual public webinar that will summarize the current approach to assessing bone health, as well as preventing and treating osteoporosis with a focus on postmenopausal women.
The Power of Asian American, Native Hawaiian and Pacific Islander Cultural Practices in Healing
May 29, 3:00 - 4:30 PM ET (9:00 AM HST • 12:00 PM PST), Virtual
This webinar will focus on applying cultural frameworks to build trust and community engagement in behavioral health care services for AANHPI communities during times of crisis. Participants will gain literacy on key cultural concepts related to health, community identity, and wellness for AANHPIs.
This webinar is presented by the Substance Abuse and Mental Health Services Administration’s (SAMHSA) Office of Behavioral Health Equity in collaboration with the AANHPI ‘Ohana Center of Excellence (CoE), Hawaiʻi Department of Health, Papa Ola Lōkahi, Ho’aka Mana, Waianae Coast Comprehensive Health Center, and California State University East Bay.
Visit the event page (here) for more information about receiving continuing education credit hours.
Opportunities
Development of a Universal Symbol for Language Assistance Services in Health Settings
The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) seeks input from language access stakeholders, including organizations representing and/or serving communities with Limited English Proficiency (LEP), to inform the development of a universal symbol informing people about the availability of language assistance services in health settings.
Comments must be submitted no later than 11:59pm on May 20, 2024.
In Case You Missed It
Everyone Can Take Steps to Keep Blood Pressure Low
No matter your age, you can take steps each day to keep your blood pressure in a healthy range. In addition to a healthy lifestyle, your healthcare provider may prescribe FDA-approved medicine. Learn more about how blood pressure medicine works.
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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