 Meet Our New Director
The FDA Office of Minority Health and Health Equity (OMHHE) is pleased to announce that Cheryl Anne Boyce, Ph.D., has been named the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. Food and Drug Administration. In this role, Dr. Boyce will guide OMHHE and the FDA’s minority health and health disparity initiatives while leading collaborative strategic efforts that advance health equity.
News At FDA
Mammography Quality Standards Act (MQSA) and MQSA Program
In observance of Breast Cancer Awareness Month, the FDA Center for Devices and Radiological Health (CDRH) is highlighting that the new requirements of the 2023 Mammography Quality Standards Act (MQSA) final rule that amended federal standards to incorporate current science and mammography best practices are now in effect.
FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect
The FDA is pleased to announce that the unified Human Foods Program, a new model for field operations and other modernization efforts, is now in effect.
FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia
The FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.
FDA Approves First Treatment for Niemann-Pick Disease, Type C
The FDA approved Miplyffa (arimoclomol), an oral medication for the treatment of Niemann-Pick disease, type C (NPC). Miplyffa, in combination with the enzyme inhibitor miglustat, is approved to treat neurological symptoms associated with NPC in adults and children 2 years of age and older. Miplyffa is the first drug approved by the FDA to treat NPC. NPC is a rare genetic disease that results in progressive neurological symptoms and organ dysfunction.
FDA Approves New Drug to Treat Niemann-Pick Disease, Type C
The FDA approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing at least 15 kilograms. This is the second treatment the FDA has approved for NPC within the span of a week, and this action further underscores the agency’s commitment to support development of new treatments for rare diseases.
FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration
The FDA approved FluMist for self- or caregiver-administration. FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age.
Voices in Health Equity
Communicating and Engaging with Latino Communities
In honor of Hispanic Heritage Month, OMHHE invites you to watch our most recent Health Equity Lecture Series webinar titled, “Communicating and Engaging with Latino Communities.” This webinar features OMHHE’s Dr. Christine Lee speaking with researchers Dr. Rigoberto Delgado and Dr. Fabian Sandoval about their careers and ongoing work to advance health equity.
New from OMHHE: REACHing Communities Video Series
As the FDA Office of Minority Health and Health Equity (OMHHE) continues to celebrate National Hispanic Heritage Month, the office has launched the first video of the new REACHing Communities video series. The series features interviews with members of the OMHHE Racial and Ethnic Minority Acceleration Consortium for Health Equity, also known as “REACH.” In this video we hear from Ms. Perla Nunes on her ongoing work as a Project Manager and Clinical Trial Research Expert for the Federally Qualified Health Centers (FQHC) REACH Consortium and her work to increase participation in clinical trials.
Upcoming Events
FDA Grand Rounds - Acute Pain Management/Patient Experience Study in Diverse Populations
October 10, 12:00 p.m. - 1:00 p.m. ET, Virtual
This seminar will provide a rationale and overview of the Acute Pain Pathways (APP) study, a prospective cohort study conducted in collaboration with the FDA to better understand pain management and pain control among individuals experiencing acute pain for various common diagnoses.
Webinar on Voluntary Sodium Reduction Goals (Edition 2) Draft Guidance and Preliminary Assessment of Progress
October 10, 1:00 p.m. - 1:45 p.m. ET, Virtual
This stakeholder webinar will provide an overview of the recently released draft guidance outlining new, voluntary targets for sodium reduction in foods, as well as a preliminary assessment of progress 2010-2022.
2024 FDA Oncology Center of Excellence Pediatric Advocacy Forum
October 15, 9:00 a.m. - 1:00 p.m. ET, Virtual and In-person
The FDA Oncology Center of Excellence (OCE) Pediatric Oncology Program invites members of the pediatric oncology advocacy community to participate in this forum to strengthen collaboration and promote more efficient development of new safe and effective drugs and biological products for pediatric patients with cancer.
Benchmarks for Diversity in Oncology Clinical Trials: An FDA - ACS Hybrid Workshop
October 16, 8:30 a.m. - 2:45 p.m. ET, Virtual and In-person
The FDA Oncology Center of Excellence (OCE) and the American Cancer Society (ACS) are co-sponsoring a symposium focusing on setting benchmarks for diversity in oncology clinical trials.
FDA and NIH Joint Public Meeting on Advancing Smoking Cessation Priorities
October 21, 9:00 a.m. - 4:30 p.m. ET, Virtual
The FDA and NIH will host a joint public meeting focused on advancing innovation of smoking cessation products to help both adults and youth.
FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Pazdur + 25—Celebrating a Silver FDA Anniversary”
October 23, 2:00 p.m. - 3:00 p.m. ET, Virtual
Join the FDA Oncology Center of Excellence (OCE) for a panel with OCE Center Director, Dr. Richard Pazdur, recognizing his 25+ years of oncology leadership.
Finding Your Support Team While Participating in a Clinical Trial
October 30, 12:00 p.m. - 3:05 p.m. ET, Virtual
The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) is hosting a public virtual webinar that will feature patients, care partners, and advocates who have direct experience building and managing support networks while navigating and participating in clinical trials.
In Case You Missed It
Should You Give Kids Medicine for Coughs and Colds?
Most colds in children don’t cause serious complications. Cough or cold medicine will not change the natural course of a cold or make it go away faster.
Caution: Bodybuilding Products Can Be Risky
The FDA found some bodybuilding products may illegally contain steroids or steroid-like substances associated with potentially serious health risks which can be life-threatening.
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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