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FDA Issues Draft Guidance on Including Pregnant Women in Clinical Trials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FDA Issues Draft Guidance on Including Pregnant Women in Clinical Trials

May 3, 2018 — The U.S. Food and Drug Administration (FDA) recently announced the availability of a draft guidance for industry entitled, “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.”

This draft guidance discusses the ethical and scientific issues when considering the inclusion of pregnant women in clinical trials of drugs and biological products. This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection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

The cartilage in this MRI scan of a knee is colorized to show greater contrast between shades of gray.

The cartilage in this MRI scan of a knee is colorized to show greater contrast between shades of gray. Image courtesy of Kundu et al. (2020) PNAS

News | Artificial Intelligence | September 22, 2020
September 22, 2020 — Researchers at the University of Pitts...
New research from King's College London has found that COVID-19 may be diagnosed on the same emergency scans intended to diagnose stroke.

Canon Medical Systems

News | Cardiac Imaging | September 22, 2020
September 22, 2020 — New research from King's College London has
The COVID-19 pandemic has impacted every facet of personal life, business operations and healthcare, including breast imaging and breast cancer care.

Getty Images

Feature | Breast Imaging | September 18, 2020 | By Susan Harvey, M.D.
The COVID-19 pandemic has impacted every facet o
Ultrasound-guided carpal tunnel release quickly improves hand function and reduces hand discomfort, making the procedure a safe, effective, and less invasive alternative to traditional open or endoscopic surgery

Patients answered three questionnaires (Quick-Disabilities of the Arm, Shoulder, and Hand [QDASH] and two parts of the Boston Carpal Tunnel Syndrome Questionnaire: symptom severity [BCTSQ-SS] and functional status [BCTSQ-FS] scales) assessing the affected wrist's function and discomfort immediately pre-procedure, 2 weeks post-procedure, and at least one year post-procedure. Infographic courtesy of the American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR)

News | Ultrasound Imaging | September 17, 2020
September 17, 2020 — According to ARRS' American Journal of Roentgenology (AJR),...
HABLE study prioritizes brain imaging and biomarker research among Mexican Americans.

Getty Images

News | PET Imaging | September 14, 2020
September 14, 2020 — To meet the pressing need to better understand the prevalence, progression, and clinical impact
Six months after deployment, the no-show rate of the predictive model was 15.9%, compared with 19.3% in the preceding 12-month preintervention period — corresponding to a 17.2% improvement from the baseline no-show rate (p < 0.0001). The no-show rates of contactable and noncontactable patients in the group at high risk of appointment no-shows as predicted by the model were 17.5% and 40.3%, respectively (p < 0.0001).

Weekly outpatient MRI appointment no-show rates for 1 year before (19.3%) and 6 months after (15.9%) implementation of intervention measures in March 2019, as guided by XGBoost prediction model. Squares denote data points. Courtesy of the  American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR)

News | Artificial Intelligence | September 10, 2020
September 10, 2020 — According to ARRS’
UT Dallas study aims to advance thermography for monitoring tumors

Adolfo Lozano, PhD'20, works on a proof-of-concept computer model of the thermal properties of breast cancer. He and other UT Dallas researchers aim to improve digital thermal imaging as a tool for monitoring cancer and its treatment. Image courtesy of The University of Texas at Dallas

News | Breast Imaging | September 09, 2020
September 9, 2020 — ...
High-intensity focused ultrasound (HIFU), a technology used to treat localized prostate cancer, has shown adequate control of prostate cancer while avoiding major side effects of surgery or radiation therapy, according to a new study in The Journal of Urology, Official Journal of the American Urological Association

Getty Images

News | Prostate Cancer | September 08, 2020
September 8, 2020 — Approved by the US Food and Drug Administration (FDA) in 2015 for prostate tissue ablation, the h