Help Stop the Spread of Coronavirus and Protect Your Family | FDA

Help Stop the Spread of Coronavirus and Protect Your Family | FDA

Message from the Associate Commissioner

Dear Women’s Health Colleagues,

The Office of Women’s Health (OWH) strives to enhance the regulatory process and advance the health of women through science, outreach, and education. This month, in recognition of National Breastfeeding Month, we are highlighting our educational resources and recent activities related to maternal health.

We kicked off the month by hosting our first fully virtual seminar and welcomed Dr. Vincenzo Berghella, Director of the Maternal-Fetal Medicine Division at Thomas Jefferson University, as our featured speaker for our OWH Scientific Seminar Series. Dr. Berghella gave an informative lecture and shared his insights on COVID-19 and pregnancy with FDA staff. 

I am also pleased to inform you that FDA issued a draft guidance last month to assist applicants in complying with the content and format requirements for the Pregnancy, Lactation, and Females and Males Reproductive Potential subsections of the label for human prescription drugs and biological products. The FDA product label serves as a critical resource for healthcare providers and consumers. I encourage you to read this draft guidance and submit your comments and suggestions. I also invite you to learn about FDA’s educational resources for nursing mothers in the Call to Action section below.

As mentioned in last month’s newsletter, OWH is soliciting input to help inform our strategic priorities. The Federal Register public docket will be open for comments until September 8, 2020. We look forward to receiving your feedback.

Sincerely,

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

Associate Commissioner for Women's Health

Director, Office of Women's Health

CORONAVIRUS

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

• FDA Consumer Update: Help Stop the Spread of Coronavirus and Protect Your Family
• FDA Updates on Hand Sanitizers Consumers Should Not Use
• FDA Authorizes First Two Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection
• Findings from Real-World Data Study Reveal Higher Risk of Hospitalization and Death Among Cancer Patients with COVID-19, Underscore Health Disparities