Women's Health Newsletter - August 2023

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Message from the Associate Commissioner

Dear Women’s Health Colleagues,

As we enter back-to-school season, many women experience a sense of excitement and anxiety. Anxiety can affect women whether they are students themselves, parents, or caregivers. It is important to note that anxiety is a normal reaction to stress, and it helps you cope, but anxiety disorders can happen when excessive anxiety interferes with everyday activities. Women are twice as likely as men to experience anxiety disorders.

Recognizing that many women struggle with this condition, the FDA Office of Women’s Health has published a new resource on Women and Anxiety, to help consumers learn more about symptoms, causes, and potential treatment options. Printed copies of the new fact sheet are available in English and Spanish, and free to order, along with many other OWH resources. The Women and Anxiety fact sheet is also available for download in several other languages.

This month, I also invite you to learn more about our College Women Campaign (CWC) resources and encourage you to use our CWC Digital Toolkit, and share our health tips and resources for college women with your campus community.

Sincerely,

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

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

This month, we highlight National Breastfeeding Month and Black Breastfeeding Week (August 25-31), a time to share valuable information and resources with those who are pregnant or breastfeeding.

• General breastfeeding resources: About Breastfeeding, Breastfeeding FAQ, Benefits of Breastfeeding, Why Breastfeeding Matters, Breastfeeding and Nutrition
• Breastfeeding safety: What to Know When Buying or Using a Breast Pump, Proper Storage and Preparation of Breast Milk, Cleaning a Breast Pump, Breast Pump and Breastfeeding Resources
• Breastfeeding and vaccinations: Vaccination Safety for Breastfeeding Mothers
• Multicultural resources: Breastfeeding Myths in the African-American Community, Finding Breastfeeding Support

• FDA issues draft guidance for registration and listing of cosmetic product facilities and products
• FDA approves first oral treatment for postpartum depression
• Tattoo removal: options and results
• CDER Conversation: Improving medication adherence and patient experience by researching patient perceptions of generic drugs
• FDA warns consumers that Tydemy, a prescription oral contraceptive, may have reduced effectiveness
• FDA approves dostarlimab-gxly with chemotherapy for endometrial cancer
• An update on sesame allergen labeling on food packages
• FDA approves second over-the-counter naloxone nasal spray product
• FDA takes steps to facilitate innovation for devices intended to treat opioid use disorder
• FDA approves first treatment for molluscum contagiosum
• Making sure kids are prepared if they need epinephrine treatments in school

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!

• August 22-23 - Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
• September 6 - Patient Engagement Advisory Committee Meeting
• September 14 - Webinar – Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder – Draft Guidance
• September 19-20 - Pediatric Advisory Committee Meeting
• September 29 - Public Meeting: Modernizing Recalls of FDA-Regulated Commodities

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