FDA Office of Women’s Health Newsletter – September 2023

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Message from the Associate Commissioner

Dear Women’s Health Colleagues,

I am pleased to announce that the FDA Office of Women’s Health (OWH) and Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology will hold a virtual public workshop on "Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research," on October 11, 2023, 10:00 a.m. - 2:00 p.m. (ET).

This workshop will discuss the current understanding of the impact of menopause on pharmacokinetics (PK, the movement of drugs through the body), pharmacodynamics (PD, the body's biological response to drugs), and also identify research and data gaps. We hope you can join us for this important meeting, which will include presentations and session discussions by experts in the fields of clinical pharmacology, obstetrics and gynecology, endocrinology, and clinical care. I invite you to learn more and register.

Sincerely,

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

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

The FDA Office of Women's Health has resources to help you manage health conditions and make healthy choices at www.fda.gov/womens. Learn how to use the FDA Nutrition Facts Label as a tool for maintaining healthy dietary practices. This includes details on calories, serving sizes, added sugars, and more.

This National Women's Health and Fitness Day (September 27), remember that regular physical activity benefits your health. Any physical activity is better than no physical activity. Talk with your health care provider about creating a plan to fit regular physical activity into your life.

Women’s health news and updates

• Optimizing postapproval safety studies to expand data generation on medication use in pregnancy
• FDA approves multiple generics of attention-deficit/hyperactivity disorder (ADHD) and binge-eating disorder (BED) treatment
• FDA approves first biosimilar to treat multiple sclerosis
• FDA approves first vaccine for pregnant individuals to prevent RSV in infants
• Understanding the risks and benefits of gadolinium MRI during pregnancy

More updates from around FDA

• COVID-19, flu and RSV
• FDA issues warning letters to firms marketing unapproved eye products
• FDA takes action on updated mRNA COVID-19 vaccines to better protect against currently circulating variants
• FDA issues warning letters to three infant formula manufacturers
• National Preparedness Month - tips for medical device users
• National Food Safety Education Month 2023 — people at higher risk
• Hurricane season: be prepared
• Biosimilar and interchangeable biologics: more treatment choices
• Do not use ultraviolet (UV) wands that give off unsafe levels of radiation: FDA safety communication
• Treating and dealing with attention-deficit/hyperactivity disorder (ADHD)
• Safely treating molluscum, a common skin condition
• Modernizing the recall process for a healthier America
• Tips for submitting comments on CDRH guidance documents
• Do not use tests manufactured by Universal Meditech Inc.

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!

• September 18-19 – Workshop: Optimizing the Use of Postapproval Pregnancy Safety Studies
• September 19-20 – Pediatric Advisory Committee Meeting: The committee will discuss the appropriate development plans for establishing safety and effectiveness of artificial womb technology devices, including regulatory and ethical considerations for first in human studies.
• September 29 – Public Meeting: Modernizing Recalls of FDA-Regulated Commodities
• October 11 – OWH Public Workshop: Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research
• November 29-30 – Public Workshop: Discussing Approaches to Enhance Clinical Study Diversity

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