January 2021 Office of Women's Health e-Update
Message from the Associate Commissioner
Dear Women’s Health Colleagues,
The beginning of a new year is a great time for all of us to prioritize good health and commit to making choices that enhance our overall wellness. For many of us, the challenges presented by the COVID-19 pandemic resulted in putting off annual health visits and screenings. Now is a great time to connect with your health care provider to discuss which exams you may need this year. OWH has several resources to help you maintain a lifetime of healthy habits that can be found on our OWH homepage, Knowledge and News on Women blog, and our Twitter page.
As we start 2021, the FDA continues critical work to protect public health during the COVID-19 pandemic. In this month’s OWH e-update, we are sharing important information from FDA on dosing schedules for COVID-19 vaccines and a safety communication alerting patients and health care providers of the risk of false results with the Curative SARS-Cov-2 test. Please read the detailed Agency communications below.
This year, OWH will continue our work to protect, promote and advance the health of women and we hope you continue to look to us to provide you with valuable information on critical women’s health topics.
Wishing you all a healthy New Year.
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
Below are links to specific COVID-19 topics, with a full list of the latest COVID-19 information from the FDA here.
- FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
- FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff
- Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication
WOMEN'S HEALTH HIGHLIGHTS
FDA Releases Artificial Intelligence/Machine Learning Action Plan
The U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software.
'Gluten-Free' Means What It Says
The U.S. Food and Drug Administration (FDA) wants you to know that foods labeled as "gluten-free" and with similar terms such as "without gluten," "free of gluten," and "no gluten" must meet specific criteria set by the FDA in August 2013 and August 2020. These requirements are important for people with celiac disease, who face potentially life-threatening illnesses if they eat gluten, typically found in breads, cakes, cereals, pastas, and many other foods. Some individuals may not have celiac disease but may still be sensitive to gluten.
FDA Acts to Increase the Safe Use of Laparoscopic Power Morcellators
The U.S. Food and Drug Administration issued two updates to promote the safe use of laparoscopic power morcellators during gynecologic surgery.
2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science
The 2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report outlines topics FDA has identified as needing continued targeted investment in regulatory science research to facilitate development of innovative products, provide data and methods to inform regulatory decision-making and improve guidance to sponsors. Each FARS aligns with one of four strategic initiatives.
FDA Novel Drug Approvals for 2020
In 2020, FDA Center for Drug Evaluation and Research (CDER) approved new drug therapies that will have a significant impact on improving and potentially prolonging patients’ lives.
FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine
Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases. These advances have contributed to an increase in development and approval of drugs for the treatment of rare diseases in recent years. In fact, in the past eight years, the U.S. Food and Drug Administration has approved more than twice as many drugs for rare diseases, often referred to as orphan drugs, as in the previous eight years.
FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia
The U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus.
FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs
While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis. We remain committed to using all facets of our regulatory authority to lessen the impact of opioid addiction, misuse, and abuse while also striking a careful balance between patient access and safety to ensure that patients suffering from significant pain have access to appropriate medication.
To that end, the FDA has been and continues to address this public health crisis on a number of fronts.
CALL TO ACTION
As we settle into the new year, the Office of Women’s Health reminds you that it is the perfect time to think about how you can keep your mind and body healthy, whether you just started college, are a new mom navigating motherhood, or a woman in her golden years. A woman passes many milestones throughout her life and her health should be a priority every step of the way. Learning how to make nutritious food choices, stay active, reduce stress, manage health conditions, and take time out when you need it are touchstones of self-care and can help you stay healthy and resilient. Check out this month’s OWH Blog: Knowledge and News on Women for information and resources to help you prioritize and maintain your health and wellness this year and beyond!
January is also National Birth Defects Prevention Month. We encourage you to explore our numerous resources developed to help expectant mothers make informed decisions about their medicines, foods, and other products. Please visit our FDA pregnancy webpage, download and share our medicine and pregnancy fact sheet, and share the resources in our pregnancy social media toolkit.
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
Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials Public Meeting, February 2-3, 2021
Public Meeting on Patient-Focused Drug Development for Vitiligo - March 8, 2021
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.