Women's Health E-Update March 2023

Message from the Associate Commissioner

Dear Women’s Health Colleagues,

This Women’s History Month, we are celebrating the achievements and telling the stories of women past and present from our Office of Women’s Health (OWH) and across the FDA. Women of great talent and tenacity have helped transform our communities, our nation and public health for the better. We honor their remarkable courage, conviction, and vision in the month of March and beyond.  

Please take a moment to read some of the stories of women contributing to the FDA, including Voices of Innovation: Women in Science, Technology, Engineering and Mathematics and Women Inspiring Innovation Through Imagination: Celebrating Women in Science, Technology, Engineering and Mathematics .

Since 1994, OWH has led policy, research, education, and outreach efforts to advance the health of women. We are proud to continue this work and to provide a variety of health resources to help women make informed decisions for themselves and their loved ones.

I encourage you to share our resources and to also take time to listen to and share the stories of the women in your own families, communities, and workplaces. Women’s history is all around us.

Sincerely,

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

CORONAVIRUS UPDATES

Below are links to specific COVID-19 topics with a full list of the latest COVID-19 information from the FDA here.

• Know Your Treatment Options for COVID-19
• Coronavirus (COVID-19) Update: FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of Age
• FAQs: What happens to EUAs when a public health emergency ends?
• FDA Issues Federal Register Notice to Announce Status of COVID-19 Guidance Documents When Public Health Emergency Expires
• Personal Protective Equipment EUAs
• UPDATED: Why should I get my child an updated COVID-19 vaccine?
• FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses
• 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

March also marks Colorectal Cancer Awareness Month. Colorectal cancer is the third most common cancer in the United States and it’s also one of the most preventable types of cancer. One of the best ways to help prevent it is with routine screening. Health care providers recommend routine screening starting at age 45, or earlier if you are at higher risk. 

FDA has information on screening options. You can discuss these options with your health care provider to decide which is best for you. Colorectal cancer screenings can help find abnormal growths in the colon before they turn into cancer and can detect colorectal cancer in its early stages when treatment may be most effective.

Although most cases of colorectal cancer occur in people over the age of 50, rates are rising among younger adults, and African Americans and American Indians/Alaska Natives have the highest rates of colorectal cancer. Remember to schedule your screening now and talk with your friends and loved ones about how they can reduce their risk of developing colorectal cancer.   

• FDA Releases FDA Activities for the Safety of Imported Seafood
• FDA Updates Regulatory Documents to Include “Non-Tobacco Nicotine” Products
• FDA Denies Marketing of Two Vuse Solo Menthol E-Cigarette Products
• FDA approves first treatment for Rett Syndrome
• FDA Seeks $7.2 Billion to Protect and Advance Public Health by Enhancing Food Safety and Advancing Medical Product Availability
• FDA Issues Final Rule Amending Part 900 of the Mammography Quality Standards Act
• UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication
• FDA Calls for Enhanced Safety Measures in Letter to Powdered Infant Formula Industry
• Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility with HLS Set Advanced - Letter to Health Care Providers
• FDA Provides Update on Proposed Human Foods Program and Office of Regulatory Affairs Restructuring
• FDA Takes Action to Restrict Unlawful Import of Xylazine
• Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration
• FDA Outlines Steps to Strengthen Tobacco Program
• FDA Provides Draft Labeling Recommendations for Plant-based Milk Alternatives to Inform Consumers
• FDA Files Civil Money Penalty Complaints Against Four E-Cigarette Product Manufacturers
• FDA Advances Additional Activities to Prevent Drug Overdoses and Reduce Death

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!

Participate in Upcoming FDA Meetings

• UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting, March 22, 2023
• Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies Monkeypox (mpox) and COVID-19, March 22, 2023
• Virtual Public Meeting: EPA and FDA Product Oversight, March 22, 2023
• Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee Meeting Announcement, March 28-29, 2023
• Public Workshop: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review, March 28-29, 2023

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