FDA OWH newsletter – January 2024: Prioritize your health and wellness in the new year

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January 2024

Message from the Associate Commissioner

Dear Women’s Health Colleagues, 

The new year is both a time for reflection, and to envision exciting changes and opportunities. As you embrace 2024, remember to include preventive care. Preventive care can help detect serious medical conditions early so they can be treated. Schedule your annual well visit, and ask your health care provider what screenings, routine blood tests, and vaccines you may need.

This month’s Knowledge and News on Women’s Health (KNOWH) blog, Commit to a Healthier Version of You, includes information about preventive care. I hope you will read and share it, and prioritize preventive care as an important part of your healthy new year.

The OWH team is looking forward to another busy year. 2024 will mark our 30th year of protecting and promoting the health of women through policy, science, education, and outreach. I invite you to keep an eye on our OWH website, social media, and this newsletter for the latest women’s health news and events, including new education and training opportunities throughout the year. Happy New Year!

Sincerely,

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

Associate Commissioner for Women’s Health
Director, FDA Office of Women’s Health (OWH)

Did you know that most people with HPV (human papillomavirus) do not show any signs? Some kinds of HPV can cause cancer, so it is important to take preventive measures and get tested. January is Cervical Health Awareness Month. This month, learn more about HPV from OWH, and what you can do to protect your health.

Women’s health news and updates

• FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain
  FDA continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram in the legitimate U.S. drug supply chain and has seized thousands of units of the product. The agency advises wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057 as pictured here. Some counterfeit products may still be available for purchase.
• Using fat-dissolving injections that are not FDA approved can be harmful
  FDA has received reports of consumers who have used fat-dissolving injections that are not FDA approved and that have caused adverse reactions, including permanent scars, serious infections, skin deformities, cysts, and deep, painful knots. Some consumers received the injections at clinics or med spas by personnel who might not have been properly licensed to give the injections. In addition, some consumers who reported adverse reactions purchased the unapproved fat-dissolving drugs online and injected the drugs themselves.
• In case you missed it: 2023 Women’s Health Year in Review
  Learn more about how the FDA Office of Women’s Health worked to advance the health of women through scientific programs, policy development, research, education, and outreach last year.

More updates from around FDA

• Reckitt/Mead Johnson Nutrition voluntarily recalls certain Nutramigen Hypoallergenic Powdered Infant Formula products
• Letter to clinical laboratory staff and health care providers: HSV-2 tests for genital herpes can produce false reactive results
• Realizing the promise of real-world evidence
• Increasing options in clinical research to facilitate medical product development
• FDA approves first test to help identify elevated risk of developing opioid use disorder
• Know your treatment options for COVID-19
• FDA announces launch of Cosmetics Direct for electronic registration and listing of cosmetic product facilities and products

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!

• January 10, 2024 - FDA Oncology Center of Excellence, Conversations on Cancer, Bringing Innovation to People Facing Cancer (Discussion will highlight oncology drug approvals in 2023)
• January 16, 2024 - FY24 FDA Broad Agency Announcement Question and Answer Session
• January 23-24, 2024 - Virtual public meeting: Advancing Drug Development for the Prevention of Spontaneous Preterm Birth
• January 31, 2024 - Joint public meeting with Duke-Margolis: Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches
• February 2, 2024 - Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Meeting (Discussion on improving quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters submitted for premarket review, taking into consideration a patient’s skin pigmentation and patient-reported race and ethnicity.)
• March 1, 2024 - Public meeting: FDA Rare Disease Day 2024
• March 19-20, 2024 - Public workshop: Enhancing Adoption of Innovative Clinical Trial Approaches 

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