New FDA guidance on clinical trial inclusion
August 28, 2025 3 min read Add topic to email alerts Receive an email when...
FDA
FDA Announces Availability of ICH Draft Guidance on Inclusion of Pregnant and Breastfeeding Women in Clinical Trials
On Monday, July 21, 2025, the Food and Drug Administration (FDA) issued draft guidance entitled “E21 Inclusion of Pregnant and...
Women and Anxiety | FDA
Image Download English PDF (4.63 MB) En Español On this page: What is anxiety?Anxiety is a feeling of worry, nervousness, or fear about...
New FDA initiatives focus on medication safety for pregnant and nursing women
Women who are pregnant or breastfeeding often need to take prescription medications. The use of prescription medication during pregnancy and...
Medicine and Pregnancy | FDA
Image On this page: Are you pregnant and taking medicines? You are not alone. There are about 6 million pregnancies...
FDA rejects MDMA therapy for treatment of PTSD. What’s next?
MDMA came close to becoming medicine on Friday, but it missed the mark. The Food and Drug Administration declined to...
