Women's Health E-Update February 2023

Message from the Associate Commissioner

Dear Women’s Health Colleagues,

According to CDC, despite increases in awareness over the past decades, only 56% of women recognize that heart disease is the leading cause of death for women in the United States. FDA Office of Women’s Health (OWH) is committed to advancing knowledge about heart disease in women through our education, outreach, and research efforts. We are excited about new studies underway including one to understand the unique symptoms of women with coronary artery disease, which is the most common type of heart disease. I invite you to learn more about how OWH funded research on heart disease in women has provided valuable insights and bridged important knowledge gaps.   

This American Heart Month, let’s work together to take steps to create awareness among women about reducing risk factors, recognizing symptoms, and making heart healthy changes. We encourage you to share these heart-related resources with your communities: Knowledge and News on Women’s Health (KNOWN) Blog, Heart Health for Women Partner Social Media Toolkit, and other heart health for women resources.

Sincerely,

Kaveeta P. Vasisht, M.D., Pharm.D.

CORONAVIRUS UPDATES

• Extended Expiration Date: CareStart COVID-19 Antigen Home Test and On/go COVID-19 Self-Test
• Report Your At-Home COVID-19 Test Result to MakeMyTestCount.org
• FDA Announces Evusheld is not Currently Authorized for Emergency Use in the U.S.
• Extended Expiration Dates: BinaxNOW, MaximBio ClearDetect, and iHealth COVID-19 Tests

February is Black History Month! As we honor the contributions of Blacks in America, we want to create awareness of the importance of health and wellness of Black women in the communities we serve.

Please share our important women’s health and safety resources on topics such as diabetes, pregnancy, uterine fibroids, mammography, and healthy aging with your friends, family, community members, and patients. Learn more about OWH and other resources for women at www.fda.gov/womens.

• FDA Authorizes Xpert Mpox Test
• Access to Naloxone Can Save a Life During an Opioid Overdose 
• FDA Division of Drug Information’s New Q&A with FDA Podcast
• FDA Warns Consumers Not to Purchase or Use EzriCare Artificial Tears due to Potential Contamination
• FDA Approves First Oral Treatment for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis
• FDA Issues Draft Guidance Related to Drug and Biologics Clinical Trials
• FDA Proposes Individual Risk Assessment for Blood Donations, While Continuing to Safeguard U.S. Blood Supply
• FDA Issues Response to Three Citizen Petitions Related to CBD and Dietary Supplements
• FDA Announces Action Levels for Lead in Categories of Processed Baby Foods
• FDA Issues Guidance to Help Increase Supply of Ibuprofen Oral Suspension Products in Hospitals and Health Systems
• FDA Issues Guidance on Clinical Research with Cannabis

Pregnancy exposure registries are studies that collect health information on exposure to medical products such as drugs and vaccines during pregnancy.  Learn more about pregnancy registries today!

• Public Meeting: FDA Rare Disease Day 2023, February 27, 2023. This year’s theme is “Intersections with Rare Diseases – A patient focused event” which will explore a range of topics related to rare diseases.
• Stakeholder Webinar on Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry, March 2, 2023
• FDA Announces Joint Virtual Public Meeting with Reagan-Udall Foundation on Understanding Fatal Overdoses, March 8-9, 2023

Visit FDA Meetings, Conferences and Workshops to find out about available meetings.