Message from the Associate Commissioner
Dear Women’s Health Colleagues,
As the year comes to an end, I invite you to explore the new materials OWH developed in 2022. This year, we aimed to bring broader awareness to uterine fibroids under our KNOWH (Knowledge and News on Women’s Health) initiative. New resources include the informational video Invisible Pain: What Are Uterine Fibroids?, a personal testimonial, and an educational fact sheet that we encourage you to share with your communities.
OWH supports FDA’s public health mission by leading scientific programs, research and educational outreach initiatives that promote a greater understanding of women’s health topics and FDA regulated products. Our recent continuing education webinar series and scientific meeting focused on pregnancy and lactation exemplify some of our efforts to bridge critical knowledge gaps. Please view these resources to learn more.
I would like to thank you for your continued support of OWH and acknowledge the hard work of our dedicated staff. As we approach 2023, we remain steadfast in our commitment to improve the health of women.
We look forward to connecting with you in the New Year.
Sincerely,
Kaveeta P. Vasisht, M.D., Pharm.D.
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Associate Commissioner for Women’s Health
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Director, Office of Women’s Health (OWH)
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INFANT FORMULA
For the latest infant formula information and ongoing FDA efforts to increase supply, click here.
CORONAVIRUS UPDATES
Below are links to specific COVID-19 topics, with a full list of the latest COVID-19 information from the FDA here.
  HIV, the virus that causes AIDS, is one of the world’s most serious public health challenges, including in the United States. During International AIDS Awareness Month, we are reminded that while great progress has been made in preventing and treating HIV, there is still much to do.
Every year, thousands of women are infected with HIV. Read our Knowledge and News on Women’s Health blog to learn about resources for women on HIV testing, prevention, and treatment. Resources include our women and HIV fact sheet and booklet on medicines approved by FDA to treat HIV.
Together, we can all play a role in the continued world fight against HIV and AIDS.
 Should You Give Kids Medicine for Coughs and Colds?
Although most colds in children don’t cause serious complications, they can cause stress and worry in parents and caregivers. It’s understandable that you might want to give your child medicine to treat a cold. But most children will get better on their own, and cough or cold medicine will not change the natural course of a cold or make it go away faster.
Protect Your Family From Fraudulent Flu Products
Influenza season may bring out dishonest sellers hawking fraudulent products that claim to prevent, treat, or cure the flu. These unproven products, sold online and in stores, haven’t been evaluated by the FDA for safety and effectiveness. In fact, they might be dangerous to you and your family.
Body Sculpting: Information and Resources About Benefits and Risks of Non-invasive Body Contouring Devices
The U.S. Food and Drug Administration (FDA) is providing information and resources for consumers about the different types of non-invasive body contouring technologies, sometimes referred to as body sculpting, the risks associated with devices, and how to report a problem with or after the use of any medical device.
FDA Provides Update on External Evaluation to Strengthen Agency’s Human Foods Program
In July, an external evaluation of the U.S. Food and Drug Administration’s Human Foods Program, including the Office of Food Policy and Response (OFPR), the Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parts of the Office of Regulatory Affairs (ORA) was commissioned. The external evaluation, conducted by an expert panel facilitated by the Reagan-Udall Foundation, was asked to assess the processes and procedures, resourcing, and organizational structure for the Foods Program. The panel released its findings and recommendations to the agency.
Update on Endologix AFX Endovascular AAA Graft Systems and Risk of Type III Endoleak: FDA Safety Communication
The U.S. Food and Drug Administration (FDA) is updating our January 2022 safety communication on the use of Endologix AFX endovascular grafts used to treat patients with abdominal aortic aneurysm (AAA).
FDA Extends Comment Period for Proposed Rule Entitled: Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”
The U.S. Food and Drug Administration (FDA) is extending the comment period for the proposed rule entitled Food Labeling: Nutrient Content Claims; Definition of Term “Healthy” that appeared in the Federal Register on September 29, 2022. The new deadline for comments is February 16, 2023. The FDA is extending the comment period by 50 days in response to a request from stakeholders to allow additional time for interested persons to develop and submit comments.
Update on Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled in June 2021
The U.S. Food and Drug Administration (FDA) provided updated information about medical device reports received from August 1 to October 31, 2022, that are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021.
New Drug Safety Communication on Prolia (denosumab)
The U.S. Food and Drug Administration (FDA) is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). Our review of interim results from an ongoing safety study of Prolia suggests an increased risk of hypocalcemia, or low calcium levels in the blood, in patients with advanced kidney disease. Preliminary results from a separate internal FDA study further investigating hypocalcemia in dialysis patients treated with Prolia show a substantial risk with serious outcomes, including hospitalization and death.
How to Buy Medicines Safely From an Online Pharmacy
How can you tell if an online pharmacy is operating legally? The FDA’s BeSafeRx site can help you identify and avoid dangerous online pharmacies. You can protect yourself and your family by being cautious when buying medicine online. Some pharmacy websites operate legally and offer convenience, privacy, cost savings and safeguards for purchasing medicines. But not all websites are the same. The FDA has tips for buying medicines online safely.
FDA Warns Companies for Illegally Selling Food and Beverage Products that Contain CBD
The U.S. Food and Drug Administration posted warning letters to five companies for illegally selling products containing cannabidiol (CBD). These companies are selling CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD. CBD-containing products in forms that are appealing to children, such as gummies, hard candies, and cookies, are especially concerning.
FDA Approves First Drug That Can Delay Onset of Type 1 Diabetes
The U.S. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.
FDA Warns Seven Companies for Selling Dietary Supplements with Claims to Treat Cardiovascular Disease
The U.S. Food and Drug Administration (FDA) issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease or related conditions, such as atherosclerosis, stroke or heart failure, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is urging consumers not to use these or similar products because they have not been evaluated by the FDA to be safe or effective for their intended use and may be harmful.
How to Buy Medicines Safely from an Online Pharmacy
How can you tell if an online pharmacy is operating legally? The FDA’s BeSafeRx site can help you identify and avoid dangerous online pharmacies.
You can protect yourself and your family by being cautious when buying medicine online. Some pharmacy websites operate legally and offer convenience, privacy, cost savings and safeguards for purchasing medicines. But not all websites are the same. The FDA has tips for buying medicines online safely.
FDA Warns Firms for Selling Illegal E-cigarettes That Look Like Toys, Food, and Cartoon Characters
The U.S. Food and Drug Administration issued warning letters to five firms for the unauthorized marketing of 15 different e-cigarette products. Each e-cigarette product is packaged to look like toys, food, or cartoon characters and is likely to promote use by youth. None of the manufacturers submitted a premarket application for any of the unauthorized products.
FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use
The U.S. Food and Drug Administration issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status. Naloxone is a medicine that can help reduce opioid overdose deaths and when administered timely, usually within minutes of the first signs of an opioid overdose, can counter the overdose effects.
Results from the Annual National Youth Tobacco Survey
FDA and Centers for Disease Control and Prevention (CDC) released federal data from the 2022 National Youth Tobacco Survey (NYTS) on youth tobacco use in the Morbidity and Mortality Weekly Report: “Tobacco Product Use among Middle and High School Students — United States, 2022.” Findings show that in 2022, more than 1 in 10 middle and high school students (3.08 million) had used a tobacco product during the past 30 days - including 16.5% of high school and 4.5% of middle school students.
Should Your Child Participate in a Clinical Trial?
Clinical trials help provide reliable evidence needed when studying medical products to diagnose, prevent, treat, and sometimes even cure, childhood diseases. Children who participate in these research studies may also potentially benefit from the medical products under investigation.
Before deciding whether your child should participate in a clinical trial, there’s a lot to know, including the risks and benefits.
 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.
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.
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