Message from the Associate Commissioner
Dear Women’s Health Colleagues,
Women’s History Month is a great time to reflect on important past and present contributions women have made to support FDA’s regulatory mission. From conducting field inspections to medical product reviews, women across the Agency have played a pivotal role in protecting and promoting public health. OWH is honored to be a part of these efforts.
Recently, we collaborated with FDA’s Center for Drug Evaluation and Research to publish a review assessing the impact of FDA policy on drugs withdrawn from the market for safety-related reasons from 2001 to 2018. FDA has made measurable progress incorporating considerations of sex and gender differences into drug trial development and FDA review of these data. To learn more, I encourage you to read Food and Drug Administration Beyond the 2001 Government Accountability Office Report: Promoting Drug Safety for Women.
You may also be interested in learning about FDA’s recent authorization of the first robotically assisted surgical device for performing transvaginal hysterectomies. Read more about this authorization and other FDA news and safety alerts in this month’s e-update.
Thank you for your continued support.
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
Below are links to specific COVID-19 topics, with a full list of the latest COVID-19 information from the FDA here.
- FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process
- Coronavirus (COVID-19) Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs
- Know Your Treatment Options for COVID-19
- Coronavirus (COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test
- Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
- Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test
- FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally Offering Thermal Imaging Systems for Sale
- National Consumer Protection Week: FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams
- Coronavirus (COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test
- FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine
- USDA, FDA Underscore Current Epidemiologic and Scientific Information Indicating No Transmission of COVID-19 Through Food or Food Packaging
CALL TO ACTION
National Women and Girls HIV/AIDS Awareness Day (March 10) and National Native HIV/AIDS Awareness Day (March 20) are yearly observances to recognize the impact of HIV/AIDS on women and girls, as well as American Indians, Alaska Natives, and Native Hawaiians. The awareness days are intended to spark conversation, bring HIV/AIDS awareness to the forefront, empower these groups to get tested and highlight the work being done to reduce HIV in the United States. Get the facts on HIV testing, prevention and treatment for women here, and our HIV and AIDS medicines booklet here.
WOMEN'S HEALTH HIGHLIGHTS
The FDA Provides Updates on Adverse Event Reports Associated with Essure
The U.S. Food and Drug Administration (FDA) remains committed to collecting and providing updates on the long-term safety information about Essure. Although Essure, a permanently implanted birth control device for women, has not been available for implantation since December 2019, the FDA continues to monitor the product’s safety through postmarket surveillance study data and other activities. The FDA provides updates on the ongoing postmarket evaluation of Essure.
Risk of Device Component Breaking in Patients with Stryker’s STAR Ankle: FDA Safety Communication
The U.S. Food and Drug Administration (FDA) is advising patients, caregivers, and health care providers about the higher than expected risk of the polyethylene (plastic) component of the device breaking (fracture), as early as three to four years after implantation in all Scandinavian Total Ankle Replacement devices (STAR Ankle). Fracture of the plastic component of the STAR Ankle may lead to surgery to repair or replace the device.
FDA Announces New Actions Aimed at Further Reducing Toxic Elements in Food for Babies, Young Children
The U.S. Food and Drug Administration (FDA) takes exposure to toxic elements, such as arsenic, mercury, cadmium and lead, in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population. FDA announced new actions aimed at further preventing or reducing chemical hazards that may be present in foods for babies and young children.
Formaldehyde in Hair Smoothing Products: What You Should Know
The Food and Drug Administration released important information on formaldehyde and hair smoothing products. Most hair smoothing or straightening products release formaldehyde gas into the air during the hair straightening or smoothing process. Formaldehyde gas is a known human carcinogen as classified by the International Agency for Research on Cancer and formaldehyde exposure can cause both short- and long-term health effects. The FDA reminds you to get the facts before using hair-smoothing products.
FDA Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy
The U.S. Food and Drug Administration has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy in certain patients. The Hominis Surgical System is intended for benign hysterectomy (removal of the uterus for non-cancerous conditions) with salpingo- oophorectomy (removal of one or both fallopian tubes and ovaries).
FDA Authorizes Marketing of Novel Device to Help Protect Athletes’ Brains During Head Impacts
The U.S. Food and Drug Administration authorized marketing of a new device intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in the protection of the brain from the effects associated with repetitive sub-concussive head impacts. The non-invasive device, called Q-Collar, is a C-shaped collar that applies compressive force to the neck and increases blood volume to help reduce movement of the brain within the cranial space which may occur during head impacts. The device may reduce the occurrence of specific changes in the brain that are associated with brain injury.
FDA Advises Parents and Caregivers to Not Make or Feed Homemade Infant Formula to Infants
The FDA is advising parents and caregivers to not make or feed homemade infant formula to infants. Parents or caregivers of infants who have consumed a homemade infant formula should contact their healthcare provider and report any symptoms to their local Health Department.
FDA Warns 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Depression and Other Mental Health Disorders
The U.S. Food and Drug Administration announced warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: Enlifta LLC; Lifted Naturals; Mountain Peak Nutritionals; SANA Group LLC.; Wholesome Wellness; Dr. Garber’s Natural Solutions; ProHealth Inc.; Blossom Nature LLC; FDC Nutrition Inc.; and Silver Star Brands, Inc.
Recommendations About the Use of Dental Amalgam in Certain Higher-Risk Groups
U.S. Food and Drug Administration (FDA) has developed graphics that provide a visualization of recommendations about the use of dental amalgam (a mercury-containing dental restorative or filling material) in certain groups of people who may be at greater risk for potential harmful health effects of mercury exposure.
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
- Roadmap to 2030 for New Drug Evaluation in Older Adults
- Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups
- April 6, 2021: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.