News | Women's Health | May 03, 2018

FDA Issues Draft Guidance on Including Pregnant Women in Clinical Trials

Guidance explores the ethical and scientific issues of including pregnant women in trials, allowing women who become pregnant to continue the trial

FDA Issues Draft Guidance on Including Pregnant Women in Clinical Trials

May 3, 2018 — The U.S. Food and Drug Administration (FDA) recently announced the availability of a draft guidance for industry entitled, “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.”

This draft guidance discusses the ethical and scientific issues when considering the inclusion of pregnant women in clinical trials of drugs and biological products. This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations.

Read the full guidance document here.

For more information: www.fda.gov

 

Related Content

RSNA Study Shows Real-Time Indicator Improves Mammographic Compression
News | Mammography | December 12, 2018
Sigmascreening recently announced that more than 100,000 women have had mammography exams with the Sensitive Sigma...
Massachusetts Superior Court Grants Hologic Preliminary Injunction in Trade Secrets Lawsuits
News | Mammography | December 12, 2018
December 12, 2018 — A Massachusetts Superior Court granted a preliminary injunction in lawsuits by Hologic against Ch
Videos | Mammography | December 10, 2018
Stamatia Destounis, M.D., FACR, associate professor, University of Rochester School of Medicine, and attending radiol
Youth Football Changes Nerve Fibers in Brain

Statistically significant clusters (red-colored) showing group differences (Control vs. Football) in white matter strain along the primary (F1) and secondary (F2) fibers. While body of corpus callosum (BBC) showed relative shrinkage in Football group, the other clusters showed relative stretching of fibers. PCR: Posterior Corona Radiata, PLIC: Posterior Limb of Internal Capsule, SCR: Superior Corona Radiata, SLF: Superior Longitudinal Fasciculus, SCC: Splenium of Corpus Callosum. Image courtesy of Kim et al.

News | Neuro Imaging | December 07, 2018
Magnetic resonance imaging (MRI) scans show repetitive blows to the head result in brain changes among youth football...
FDA Clears iCAD's ProFound AI for Digital Breast Tomosynthesis
Technology | Mammography | December 07, 2018
iCAD Inc. announced clearance by the U.S. Food and Drug Administration (FDA) for their latest, deep-learning, cancer...
Fujifilm Collaborates With Lunit on AI Pilot Project
News | Artificial Intelligence | December 05, 2018
Fujifilm Medical Systems USA Inc. announced a joint collaboration with Korean-based medical artificial intelligence (AI...
ScreenPoint Medical and Volpara Partner to Bring AI to Breast Imaging Clinics
News | Computer-Aided Detection Software | December 04, 2018
ScreenPoint Medical has signed a memorandum of understanding (MOU) with Volpara Health Technologies. Volpara will...
GE Healthcare Introduces Invenia ABUS 2.0
Technology | Ultrasound Women's Health | December 03, 2018
GE Healthcare recently launched the Invenia automated breast ultrasound (ABUS) 2.0 system in the United States. This...
Snoring Poses Greater Cardiac Risk to Women
News | Women's Health | November 29, 2018
Obstructive sleep apnea (OSA) and snoring may lead to earlier impairment of cardiac function in women than in men,...
ScreenPoint Medical Receives FDA Clearance for Transpara Mammography AI Solution
Technology | Computer-Aided Detection Software | November 28, 2018
November 28, 2018 — ScreenPoint Medical announced it has received 510(k) clearance from the U.S.