Message from the Associate Commissioner
Dear Women’s Health Colleagues,
Next week, on Thursday, November 19, 2020, we are excited to host a public meeting to discuss potential sex and gender differences in use and responses to cannabidiol (CBD) and other cannabinoids. Researchers, educators, clinicians, and patients may benefit from attending this multidisciplinary scientific conference. Learn more about the meeting here.
I am pleased to share the availability of the final guidance for industry entitled, Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria, Enrollment Practices, and Trial Designs. This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials. Learn more about the final guidance in the Women's Health Highlights below. In addition, FDA released a report that summarizes trial populations presented in all Drug Trials Snapshots (DTS) for drugs approved between January 2015 and December 2019. Learn more about the DTS report here.
I also encourage you to read our latest OWH Knowledge and News on Women blog post. In recognition of National Diabetes Month, this month’s blog features Dr. Susan Mayne, Director, FDA Center for Food Safety and Applied Nutrition (CFSAN). Dr. Mayne shares insights on how recent updates to the Nutrition Facts label can help individuals living with diabetes.
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
Below are additional links to specific COVID-19 topics, with a full list of the latest COVID-19 information from the FDA here.
WOMEN'S HEALTH HIGHLIGHTS
FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development
To further promote and protect public health, it is important that people who are in clinical trials represent the populations most likely to use the potential medical product. In that spirit, the U.S Food and Drug Administration issued final guidance with the agency’s recommendations on designing and executing clinical trials of drugs and biologics that include people with different demographic characteristics (e.g., sex, race, ethnicity, age, location of residency) and non-demographic characteristics (e.g., patients with organ dysfunction, comorbid conditions, and disabilities; those at weight range extremes; and populations with diseases or conditions with low prevalence).
FDA Approves Treatment to Reduce the Incidence and Severity of Cardiomyopathy Associated with Doxorubicin Administration in Women with Metastatic Breast Cancer
FDA Approves Lotion for Nonprescription Use to Treat Head Lice
The U.S. Food and Drug Administration approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA initially approved Sklice (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older as a prescription drug in February 2012.
Advisory Committees Give FDA Critical Advice and the Public a Voice
At the U.S. Food and Drug Administration, we rely on our many advisory committees to help us make sound decisions based on the best science available.
The FDA’s complex and multifaceted mission includes evaluating new medicines, including vaccines and other therapies, to determine if they are safe and effective for their intended use. FDA advisory committees give our own agency experts outside, independent, and professional advice on various complex scientific, technical, and policy issues.
FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications
The U.S. Food and Drug Administration announced today in a Drug Safety Communication that it is requiring labeling changes for nonsteroidal anti-inflammatory drugs (NSAIDs). These changes include new labeling to explain that if women take the medications around 20 weeks or later in their pregnancy, the drugs can cause rare but serious kidney problems in the unborn baby, which can lead to low levels of amniotic fluid (the protective cushion surrounding the unborn baby) and the potential for pregnancy-related complications.
NSAIDs include medicines such as ibuprofen, naproxen, diclofenac, and celecoxib. People have taken these drugs for decades to treat pain and fever from many medical conditions. There are both prescription and over-the-counter (OTC) NSAIDs.
CALL TO ACTION
November’s Knowledge and News on Women blog coincides with National Diabetes Awareness Month and provides a great opportunity to highlight how nutrition and healthy eating habits and lifestyle play important roles in diabetes management. This month’s blog is a collaboration between FDA Office of Women’s Health (OWH) and Center for Food Safety and Applied Nutrition (CFSAN).
CFSAN’s new and improved Nutrition Facts Label reflects updated scientific information, including the link between diet and chronic diseases such as diabetes. The new label makes it easier to make more informed food choices. Learn about What’s New with the Nutrition Facts Label, including details on: Calories, Serving Sizes, Added Sugars, and Percent Daily Value to help in managing diabetes. OWH has resources to help you talk with your healthcare provider about your diabetes treatment, including during pregnancy. Diabetes can be controlled by maintaining a healthy diet, exercising, and using FDA-approved diabetes medicines, insulin, and monitoring your blood sugar (called glucose) level every day.
Pregnancy Exposure Registries
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!
Participate in Upcoming FDA Meetings
CBD & Other Cannabinoids – Sex and Gender Differences in Use and Responses Scientific Conference, sponsored by FDA Office of Women’s Health November 19, 2020
Conversation on Cancer – Lung Cancer: It Can Happen to Anyone, sponsored by FDA Oncology Center of Excellence, November 19, 2020
FDA's Communications About the Safety of Medical Devices Public Meeting November 17, 2020
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.