FDA OWH newsletter – October 2023: Spread the word about the importance of mammograms

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Message from the Associate Commissioner

Dear Women’s Health Colleagues,

Each year, OWH aims to bridge knowledge gaps, identify opportunities for research, and share the latest science through our educational webinars and workshops. Last week, we hosted a virtual public meeting in collaboration with the Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology (OCP) titled Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research.

Presenters discussed the physiologic changes that occur during menopause, as well as the potential effects of menopause on the pharmacokinetics and pharmacodynamics of drugs, and how this could be considered during medical product development. If you missed it, we invite you to view the meeting program and recording.

I am also pleased to share that on November 8, 2023, we will host a virtual public webinar in collaboration with CDER’s Office of Medical Policy (OMP) titled Bringing Clinical Research to Patients. This webinar will focus on decentralized clinical trials and other novel strategies currently available for bringing clinical research to patients. Learn more about this upcoming webinar and register today.

This month, in recognition of Breast Cancer Awareness month, we are highlighting the importance of mammograms and FDA’s role in regulating mammography facilities. We invite you to learn about OWH-funded breast cancer and mammography research and view our mammography related resources in the Call To Action section of this newsletter.

Sincerely,

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

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

Help spread the word about the importance of mammograms!

This year, National Mammography Day is observed on October 20 to raise awareness about the importance of getting routine mammograms (en Español). Mammograms are the best primary screening tool to find breast cancer. They can find breast lumps at an early stage, before lumps are big enough to feel or cause symptoms. Early detection of breast cancer can lead to early treatment options, and better chances of survival. Take the time now to schedule your routine mammogram.

We encourage you to share these OWH resources with your communities and loved ones:

• October 2023 Knowledge and News on Women’s Health (KNOWH) Blog
• Mammography Social Media Toolkit - new!
• Pink Ribbon Guide - Mammography Matters - provides information on mammograms and step-by-step instructions to help plan, promote, launch, and evaluate mammography awareness events in your community.

Women’s health news and updates

• Breast cancer screening: thermogram no substitute for mammogram
• Treating migraines: ways to fight the pain with medication
• It’s a good time to get your flu vaccine (Also see: COVID-19, Flu and RSV: FDA Resources for the Fall Respiratory Illness Season)

More updates from around FDA

• FDA takes steps to advance the development of novel therapies for stimulant use disorders
• FDA authorizes updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variants
• FDA grants first marketing authorization for a DNA test to assess predisposition for dozens of cancer types
• FDA launches pilot program to help further accelerate development of rare disease therapies
• FDA draft guidance could result in safer food options for people with allergies to sesame, other food allergens
• FDA provides update on the Cronobacter prevention strategy
• Prostate cancer symptoms, tests and treatments
• FDA releases new educational video series for consumers on drug regulation

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!

• October 19, 2023 – Conversations on Cancer: Living with Metastatic Breast Cancer
• October 25, 2023 - 2023 FDA Broad Agency Announcement Day – Learn more about how FDA is advancing regulatory science and innovation through contracting, including women’s health research priorities, and how to apply for research funding through the FY24 BAA
• October 30,2023 - Defining 'Candy-Like' Nonprescription Drug Products
• November 8, 2023 – OWH & CDER/OMP virtual public webinar - Bringing Clinical Research to Patients
• November 29-30, 2023 – Public Workshop: Discussing Approaches to Enhance Clinical Study Diversity

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