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:7/30/2014)... , July 30, 2014 NexID ... and liveness detection solutions for the biometric authentication ... industry consortium revolutionizing online authentication with standards for ... Cornett , "The decision to join FIDO Alliance ... authentication pervasive in use. We believe the FIDO ...
(Date:7/30/2014)... across-the-board increase in Impact Factors for its molecular ... Reports (Thomson Reuters, 2014) show that Clinical ... in Biochemistry , Biochemical Society Transactions ... in their Impact Factors. The journals are owned ... Press Limited. , 2014 Impact Factors (2013 Impact ...
(Date:7/30/2014)... decisions about what they eat, the Food and Drug ... the Nutrition Facts label found on nearly every food ... & Engineering News (C&EN), the weekly news magazine ... and the fight that has ensued. , Britt ... while the Nutrition Facts label has remained largely the ...
Breaking Biology News(10 mins):NexID Biometrics Joins the FIDO Alliance 2Across-the-board Impact Factor increases for Portland Press Limited 2
... Cornell University evolutionary biology research shows how plants at ... that influence ecosystem dynamics as well. ( Science, ... most organisms is dictated by their evolutionary history," said ... (EEB), the study,s senior author. In food webs, ...
... This release is available in Spanish . ... Agricultural Research and Development (Neiker-Tecnalia) has questioned the generally held ... exposure to natural light and states that the most determining ... Institute,s Department of Agricultural Production and Protection and opens up ...
... A protein discovered in fruit fly eyes has brought ... heart and other organs automatically "right size" themselves, a piece ... The protein, named Kibra, is linked to a relay ... by coordinating control of cell proliferation and death, according to ...
Cached Biology News:Move over predators: Plants can control the food chain too -- from the bottom up 2The quality of the tomato depends more on temperature than on natural light 2How does a heart know when it's big enough? 2
(Date:7/29/2014)... (PRWEB) July 30, 2014 ... and collaboration company, is proud to announce the ... management positions in their Boston, Charleston and Atlanta ... to the increased demand for hosted solutions, collaboration ... efficiency and reduce cost. , SoundConnect was founded ...
(Date:7/29/2014)... Bellingham, WA (PRWEB) July 29, 2014 ... manipulation of the brain that are driving a revolution ... a new peer-reviewed journal published by SPIE, ... The first issue coincides with the launch of the ... section features articles that lay out a vision for ...
(Date:7/29/2014)... Quantum Cheshire Cat: Can a particle be separated from ... Nature Communications , published the results of the first ... field, conducted by Chapman University in Orange, CA, and ... seen a cat without a grin," thought Alice in ... most curious thing I ever saw in my life!" ...
(Date:7/29/2014)... July 29, 2014  The Society for Clinical ... updated program for the 9 th annual ... in Amelia Island , Florida.  The focus ... remains unchanged, however, the topics and format will ... opportunity among all stakeholders with a continued focus ...
Breaking Biology Technology:SoundConnect Organization and Culture is Evolving 2SPIE Launches 'Neurophotonics' Journal with Special Section on BRAIN Initiative 2SPIE Launches 'Neurophotonics' Journal with Special Section on BRAIN Initiative 3SPIE Launches 'Neurophotonics' Journal with Special Section on BRAIN Initiative 4The quantum Cheshire cat: Scientists separate a particle from its properties 2The quantum Cheshire cat: Scientists separate a particle from its properties 3The quantum Cheshire cat: Scientists separate a particle from its properties 4TransCelerate, Lilly, Pfizer, and FDA Highlight Collaborative Program at the Site Solutions Summit 2TransCelerate, Lilly, Pfizer, and FDA Highlight Collaborative Program at the Site Solutions Summit 3
... (Nasdaq: ITMN ) today announced additions to ... of Esbriet™ (pirfenidone) in Europe.  InterMune,s Marketing Authorization Application ... is now awaiting ratification by the European Commission. ... of InterMune, said, "We are very pleased by the ...
... Dec. 17, 2010 RIFM, through its sponsorship of ... announce the resulting paper, Integrating population modeling into ... al , published in Integrated Environmental Assessment and Management ... of this journal according to Wiley-Blackwell and SETAC, publishers, ...
... from the Institut Catal de Nanotecnologia (ICN), in Barcelona, has ... electric currents, a key step in developing the spin computers ... 17 issue of the journal Science. The authors are Marius ... is leader of the Physics and Engineering of Nanodevices Group ...
Cached Biology Technology:InterMune Announces Senior Leadership Appointments to Prepare for Launch of Esbriet™ (Pirfenidone) in Europe 2InterMune Announces Senior Leadership Appointments to Prepare for Launch of Esbriet™ (Pirfenidone) in Europe 3InterMune Announces Senior Leadership Appointments to Prepare for Launch of Esbriet™ (Pirfenidone) in Europe 4InterMune Announces Senior Leadership Appointments to Prepare for Launch of Esbriet™ (Pirfenidone) in Europe 5InterMune Announces Senior Leadership Appointments to Prepare for Launch of Esbriet™ (Pirfenidone) in Europe 6RIFM Co-Authors Environmental Article - Among Top 5 Most Downloaded 2A 'spin ratchet': A new electronic structure for generating spin current 2
Mouse monoclonal [TONI-1] to Angiotensin II Type 1 Receptor (rating: ****) ( Abpromise for all tested applications). entrezGeneID: 185 SwissProtID: P30556...
TGF-beta 1,-2,-3 MAb (Clone 1D11)...
HSV-1 gE Envelope Protein (9H3)...
... by their capacity to self renew and ... progenitor cells, which can commit to further ... (NSCs) are capable of differentiating into multiple ... During the isolation and expansion of NSCs, ...
Biology Products: