Navigation Links
FDA Seeks to Get More Women Into Trials of Medical Devices
Date:12/16/2011

FRIDAY, Dec. 16 (HealthDay News) -- Draft recommendations meant to increase the number of women in clinical trials for medical devices were released Friday by the U.S. Food and Drug Administration.

Genetics, hormones, body size, diet, social and cultural factors, and types of illness may cause women to respond differently to certain medical products and devices than men, according to the FDA.

But, women are typically underrepresented in clinical trials. For example, a 2009 study of applications for approval of cardiovascular devices found that average female enrollment in important trials that included gender information was only 33.9 percent.

The FDA's draft guidance -- intended for medical device developers and manufacturers -- includes recommendations for designing and conducting medical device clinical trials in a way that may increase the enrollment of women, said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

"The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies," he said in an FDA news release. "Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices."

The document covers study and evaluation of sex differences, data analysis, and reporting in clinical studies conducted both before and after market approval. It also deals with statistical analyses of sex differences, how to report sex-specific information in summaries, and sex-specific labeling for approved devices.

There is a 90-day public comment period on the draft guidance.

More information

Here's where you can find the draft guidance.

-- Robert Preidt

SOURCE: U.S. Food and Drug Administration, news release, Dec. 16, 2011


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. FDA Seeks Reduction in Radiation From Medical Scans
2. Summit seeks to spark call to action on facing worlds biggest challenges
3. Summit Seeks to Spark Call to Action on Facing Worlds Biggest Challenges
4. Rev. Michel Faulkner Seeks to Retire Charlie Rangel from New York's 15th Congressional Seat
5. Long Term Care Insurance Leader Seeks 320 New Agents in 2010, Following Strong 2009 Growth
6. Bench to bassinet program seeks congenital heart disease treatments
7. International summit seeks solutions to global shortage of nursing faculty
8. European collaboration seeks to create World Wide Web for robots
9. Day Twenty-Eight Seeks Krauss For 'Shelter': Film will Personalize Epidemic of Teen Pregnancy
10. RAPS Seeks Nominations for Regulatory Awards, RAPS Fellows
11. Consortium seeks best treatment for HIV-positive cancer patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/20/2017)... Los Angeles, California (PRWEB) , ... July 19, 2017 , ... ... which found that most successful weight loss surgery patients who had received a body ... Angeles Area health and beauty clinic Beverly Hills Physicians (BHP), which provides both types ...
(Date:7/20/2017)... ... July 20, 2017 , ... “Fidget”: a fun-filled, action-packed memoir ... public high school music and drama teacher who was a summa cum laude graduate ... a “Teacher of the Year” award. After her retirement from public school, Lynn continued ...
(Date:7/18/2017)... , ... July 18, 2017 , ... CannaKids, a California ... cannabis oils, announced today that at the WORLDZ Summit, taking place in Hollywood ... on the therapeutic benefits of medical cannabis for both pediatric and adult patients, and ...
(Date:7/18/2017)... VA (PRWEB) , ... July 18, 2017 , ... ... 11) , What Strategic Decisions Do You Need to Consider?, **An FDAnews ...      , 42 CFR Part 11, “Final Rule for Clinical Trials Registration ...
(Date:7/18/2017)... ... July 18, 2017 , ... ... basis, partners with the best medical professionals who offer the most effective and ... medical professional in their network, ensuring that each patient receives prompt and courteous ...
Breaking Medicine News(10 mins):
(Date:7/10/2017)... -- The Institute for In Vitro Sciences (IIVS), a ... a VITROCELL® inhalation exposure system thanks to a generous ... which is designed to replace animals in inhalation testing, ... airborne test materials in an environment that mimics the ... testing combustible tobacco products, as well as next generation ...
(Date:7/6/2017)... July 6, 2017 ThriveRx, the nutrition division of Diplomat Specialty ... to thrive on nutrition support. To celebrate its anniversary, ThriveRx ... has a fresh new look with improved organization to create the best ... ... "We,ve made ...
(Date:7/5/2017)... 5, 2017   BioLife Solutions , Inc. (NASDAQ: ... marketer of proprietary clinical grade cell and tissue ... ("BioLife"), today announced that it has reached an agreement ... largest shareholder, to modify its existing credit facility effective ... modification, WAVI agreed to exchange its existing $4.25 million ...
Breaking Medicine Technology: