The Wall Street Journal. The majority of moderate- to high-risk medical devices approved by the U.S. Food and Drug Administration lack publicly available scientific evidence to verify their safety and effectiveness despite requirements in the law, according to a study released Monday.
The US Food and Drug Administration (FDA) approves about 400 implanted medical devices each year through an abbreviated process called the 510(k) process, which only rarely requires clinical trials (studies of patients).
We Need Better Clinical Trials Our president explained to reporters why drugs have to be tested on all kinds of people to know who they work for and who can be harmed by them. Cancer patients deserve studies that include women and men, people under and over 65, and all major racial/ethnic groups. FDA […]
Our patient booklet, DCIS: What You Need to Know, helps women diagnosed with DCIS understand the difference between DCIS and Stage 1 breast cancer, and discuss treatment options with their doctor. It was funded by a grant from the DC Cancer Consortium through the Department of Health, Government of the District of Columbia, with additional support from the Jacob and Hilda Blaustein Foundation.
This Associated Press article quotes Gregg Gonsalves’ testimony at the Senate briefing hosted by the National Center for Health Research on June 12, 2014. By Matthew Perrone WASHINGTON (AP) — As an AIDS activist in the early 1990s, Gregg Gonsalves traveled to Washington to challenge the Food and Drug Administration. Gonsalves was part of the […]
By Katie Thomas, The New York Times July 31, 2014 Johnson & Johnson, which has come under withering criticism for its response to problems with some of its medical devices, won cautious praise from critics on Thursday for its decision to withdraw three products used in uterine surgery because of a risk of spreading cancerous […]