Message from the Associate Commissioner

Dear Women’s Health Colleagues,

Breast cancer is the second most common cancer among women in the United States. FDA is committed to helping the fight against breast cancer. In August, the Agency approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable (unable to be removed) or metastatic (spread to other parts of the body) HER2-low breast cancer. This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer. You can learn more about this recent approval here.

Mammograms also play a critical role in the fight against breast cancer. Screening can help find the cancer early, when it is easier to treat. Mammograms can help save lives and continue to be the best primary tool to screen for breast cancer.

While it is important to consider breast cancer screening throughout the year, October 21st is National Mammography Day, and an important reminder to raise awareness about the importance of mammograms. Our updated 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. We also encourage you to explore our mammography resources and share them with your communities.

Sincerely,

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

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

UPCOMING OFFICE of WOMEN’S HEALTH WEBINAR

On October 27, 2022, 12:00-1:00 PM ET, join the FDA Office of Women’s Health in collaboration with CDER’s Division of Pediatrics and Maternal Health for Part 2 of our discussion of the FDA Pregnancy and Lactation Labeling Final Rule, implemented in 2015. Although the current labeling system improved the presentation of information in prescription medication labeling, it highlighted the gaps in human data for medications used during pregnancy and lactation. The speakers will provide an overview of the studies enrolling pregnant and lactating individuals, the work FDA is doing to advance research in pregnant and lactating individuals, and information on how providers can become involved in advancing research in pregnant and lactating individuals. The webinar is open to the public and CME/CNE/CPE is available. Click here to register.

INFANT FORMULA

For the latest infant formula information and ongoing FDA efforts to increase supply, click here.

• FDA Pathway Supports Long-Term Stability, Diversity of Safe and Nutritious Infant Formula Supply in the U.S.
• FDA Committed to Strengthening U.S. Infant Formula Supply; Review Provides Roadmap to Support Ongoing Efforts
• FDA Concludes Internal Review of Agency Actions Related to the U.S. Infant Formula Supply

CORONAVIRUS UPDATES

Below are links to specific COVID-19 topics with a full list of the latest COVID-19 information from the FDA here.

• FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups
• FDA Releases Important Information About Risk of COVID-19 Due to Certain Variants Not Neutralized by Evusheld
• FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types

Hot flashes? Irregular periods? Mood changes? Menopause (sometimes called “the change of life”) is a normal, natural event and affects every woman differently. This World Menopause Day, October 18, the FDA Office of Women’s Health has tips and resources to help you talk to your healthcare provider about managing your symptoms before, during, and after menopause. These resources include a Menopause & Hormones - Common Questions fact sheet and a Menopause: Medicines To Help You booklet. 

FDA Approves Vaccine for Use During Third Trimester of Pregnancy to Prevent Whooping Cough in Infants Younger Than Two Months of Age

The U.S. Food and Drug Administration approved Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age.

• Read FDA News Release

New Data Show More Than 2.5 Million U.S. Youth Currently Use E-Cigarettes

The U.S. Food and Drug Administration, in coordination with the Centers for Disease Control and Prevention (CDC), released federal data from the 2022 National Youth Tobacco Survey (NYTS) on e-cigarette use among U.S. youth. The findings, published in Morbidity & Mortality Weekly Report, show that youth use of e-cigarettes remains high, with 2.5 million (9.4%) of the nation’s middle and high school students reporting current e-cigarette use.

• Learn More

FDA Takes Steps to Further Harmonize Clinical Research Regulations with HHS Common Rule

Clinical trials play a crucial role in advancing science and supporting the development of new medical products to address unmet patient needs. Reliable data from well-designed trials about a medical product’s safety and effectiveness are critical to the U.S. Food and Drug Administration’s decision-making about a product’s benefits and risks.

• Read FDA Voices

Treating and Preventing Head Lice

Head lice affect millions of children every year. Although head lice are a year-round problem, cases usually peak during back-to-school time. FDA-approved treatments for head lice include over-the-counter and prescription drugs.

• Learn More

FDA Approves New Treatment Option for Patients with ALS

The U.S. Food and Drug Administration approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. 

• Read FDA News Release

FDA Proposes Updated Definition of ‘Healthy’ Claim on Food Packages to Help Improve Diet, Reduce Chronic Disease

The U.S. Food and Drug Administration proposed updated criteria for when foods can be labeled with the nutrient content claim “healthy” on their packaging. This proposed rule would align the definition of the “healthy” claim with current nutrition science, the updated Nutrition Facts label and the current Dietary Guidelines for Americans. 

• Read FDA News Release

New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials

The U.S. Food and Drug Administration issued a draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including and protecting children in clinical trials. The draft guidance is intended to assist industry, sponsors and institutional review boards (IRBs) when considering the enrollment of children in clinical investigations of drugs, biological products and medical devices.

• Read FDA News Release

Social Media Challenges that Misuse OTC Drugs are Dangerous to Kids

Social media trends and peer pressure can be a dangerous combination to your children and their friends, especially when involving misusing medicines. Nonprescription drugs are readily available in many homes, making these challenges even riskier.

OTC drugs can pose significant risks if they’re misused or abused. Warn your children about the dangers of misusing medicines.

• Learn More

Pulse Oximeter Safety Communication Updated with Advisory Committee Meeting Information

The U.S. Food and Drug Administration (FDA) is announcing a virtual meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee on November 1, 2022, from 9 a.m. to 6 p.m. ET. The committee will discuss ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations. The committee will also discuss factors that may affect pulse oximeter accuracy and performance, the available evidence about the accuracy of pulse oximeters, recommendations for patients and health care providers, and the amount and type of data that should be provided by manufacturers to assess pulse oximeter accuracy and to guide other regulatory actions as needed.

• Read FDA Safety Communication

FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases

The U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public-private partnership aimed at advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases. The FDA and NIH have selected the Critical Path Institute (C-Path) as the convener of this partnership.

• Learn More

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!

• Hearing Announcement Involving the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee, October 17-19, 2022
• Webinar on the Proposed Changes to the Definition of “Healthy”, October 21, 2022 
• Co-sponsored Public Workshop - Expediting Innovation of Bioelectronic Implants for Vision Restoration, October 24-25, 2022
• Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation, October 27, 2022
• Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, November 1, 2022
• FDA and NIH Public Workshops on Devices for Opioid Use, November 7-8, 2022
• Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches, November 9, 2022

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