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The FDA's draft guidance -- intended for medical device developers and manufacturers -- includes recommendations for designing and conducting medical device clinical trials in a way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 "Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices."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There is a 90-day public comment period on the draft guidance.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Here's where you can find the draft guidance.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:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned ... developed to enhance the health of felines. The formula is all-natural and is made ... in the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American ... Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. ... including advance care planning, healthcare costs and patient and family engagement. , AIR ...
(Date:6/25/2016)... , ... June 25, 2016 , ... "With 30 hand-drawn ... specific project," said Christina Austin - CEO of Pixel Film Studios. , ProHand ... all within Final Cut Pro X . Simply select a ProHand generator and ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin ... injury. Recently, he has implemented orthobiologic procedures as a method for treating his ... of the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic ...
(Date:6/24/2016)... ... 24, 2016 , ... A recent article published June 14 on ... article goes on to state that individuals are now more comfortable seeking to undergo ... such as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... -- One of Australia,s successful biotechnology scientists, ... new biotechnology company, Noxopharm Limited [ABN 50 608 966 123] ("Noxopharm"). ... list on the ASX. Noxopharm is a clinic-ready company ... Phase 1 clinical study later this year. ... biggest problems facing cancer patients - the ability of cancers to ...
(Date:6/26/2016)... June 27, 2016 Jazz Pharmaceuticals plc (Nasdaq: ... under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as ... Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: CPXX ) ... Daylight Time). As previously announced on May ... definitive merger agreement under which Jazz Pharmaceuticals has commenced ...
(Date:6/26/2016)... 2016  VMS Rehab Systems, Inc. ( www.vmsrehabsystemsinc.com ) ... measures required to build a strong and stable market ... listed on the OTC Markets-pink current trading platform. ... "We are seeing an anomaly in market trading activities ... by the Company, but shareholders and market players as ...
Breaking Medicine Technology: