Navigation Links
Are enough women included in medical device studies, as required by the FDA?
Date:1/23/2014

New Rochelle, NY, January 23, 2013-The U.S. Food and Drug Administration (FDA) mandates adequate enrollment of women in post-approval studies (PAS) of medical devices to ensure that any sex differences in device safety and effectiveness are not overlooked. A group of authors from the FDA report the results of a study evaluating the participation of women and analysis of sex differences in PAS in Journal of Women's Health, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free on the Journal of Women's Health website.

Women may respond differently to medical devices due to factors such as genetics, body size, hormones, or other intrinsic sex-specific or extrinsic societal or environmental factors. They may face greater or lesser risk of adverse events or derive more or less benefit. "Based on these findings, FDA implemented new procedures to ensure participation by sex is evaluated in PAS reviews," state the authors in their article "Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration."

"It is critically important that we have adequate participation of women in clinical trials, and that we analyze sex differences in study outcomes and adverse events," says Editor-in-Chief Susan G. Kornstein, MD, Executive Director of the Virginia Commonwealth University Institute for Women's Health, Richmond, VA, and President of the Academy of Women's Health.


'/>"/>
Contact: Vicki Cohn
vcohn@liebertpub.com
914-740-2100
Mary Ann Liebert, Inc./Genetic Engineering News
Source:Eurekalert  

Page: 1

Related biology news :

1. Melting glaciers, enough sand to bury London, and ancient ecosystem engineering
2. Manatee hearing good enough to sense approaching motorboats
3. Fear of not having enough food may lead to obesity
4. Vitamin D for pregnant women and babies -- how much is enough?
5. When the soil holds not enough phosphorus
6. Native plant restoration not enough to maintain tropical dry forests in Hawaii
7. Childrens physical activity levels are not enough to counteract sedentary lifestyles
8. Valuing nature is not enough
9. How much protection is enough?
10. Reward linked to image is enough to activate brains visual cortex
11. 3 hands on nutrition classes -- Enough to impact health behaviors in lower income women
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Are enough women included in medical device studies, as required by the FDA?
(Date:4/11/2017)... 11, 2017 Research and Markets has announced ... report to their offering. ... global eye tracking market to grow at a CAGR of 30.37% ... Tracking Market 2017-2021, has been prepared based on an in-depth market ... landscape and its growth prospects over the coming years. The report ...
(Date:4/5/2017)... , April 5, 2017 Today HYPR ... that the server component of the HYPR platform is ... providing the end-to-end security architecture that empowers biometric authentication ... HYPR has already secured over 15 million users across ... manufacturers of connected home product suites and physical access ...
(Date:3/30/2017)... -- The research team of The Hong Kong Polytechnic ... by adopting ground breaking 3D fingerprint minutiae recovery and matching technology, ... accuracy for use in identification, crime investigation, immigration control, security of ... ... A research team led by Dr ...
Breaking Biology News(10 mins):
(Date:5/23/2017)... ... May 23, 2017 , ... ... of human cardiovascular cells for research and the development of cardiac regeneration ... to generate large numbers of cardiomyocytes (hPSC-CMs). Due to varying differentiation efficiencies, ...
(Date:5/23/2017)... ... May 23, 2017 , ... Energetiq Technology, a world leader ... expansion to accommodate its rapid growth. , The renovations at the company’s headquarters ... the existing areas. The expansion includes, a state-of-the-art engineering facility, and a second ...
(Date:5/22/2017)... ... May 22, 2017 , ... Stratevi, a boutique firm that partners ... Coast. It has opened an office in downtown Boston at 745 Atlantic Ave. ... more important to generate evidence on the value they provide, not just to patients, ...
(Date:5/19/2017)... ... 19, 2017 , ... In response to the strong base of evidence supporting ... announces the release of their Gait Trainer 3 with an Integrated Music Therapy option. ... to aid in rehabilitating individuals with cerebral palsy, traumatic brain injury, stroke and Parkinson’s ...
Breaking Biology Technology: