Posts Tagged ‘ patient safety ’

FDA Helps Industry Push Medical Device Innovation

Dec 4th, 2012 | By
Medical Device Innovation Consortium logo

December 4, 2012 ~ The FDA will collaborate with the medical device industry it regulates in a public-private collaboration, all to speed up the approval of new devices. The newly formed nonprofit group,  Medical Device Innovation Consortium (MDIC), has a goal of speeding up and simplifying the design and testing of medical devices, reports CBS
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Michigan Lawmaker Wants FDA Promoting Jobs, Industry

Apr 20th, 2012 | By
Rep. Mike Rogers (R-MI)

April 20, 2012 ~ Ask most Americans and they would say that the role of the U.S. Food and Drug Administration (FDA) is to protect us from unsafe food, medications and medical devices. Congressman Mike Rogers (R-MI) would like to expand the role of the FDA to include jobs promotion and growth for industry, a
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FDA: What is MDUFA? Hearings on $595 Million and What Industry Wants

Feb 14th, 2012 | By
Dr. Jeffrey Shuren

February 14, 2012 ~ What is MDUFA? The Medical Device User Fee and Modernization Act shortened from MDUFMA. Enacted in 2002 and again in 2007 it authorized the FDA to collect a user fee from industry to review medical devices before they go on sale. MDUFA in 2010 funded about 20 percent of the medical
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Call to Action – House Energy & Commerce Committee Hearings on Mesh

Feb 12th, 2012 | By
Rep. Cliff Stearns (R-Fl)

  House Democrats are asking Republicans for a hearing on Johnson & Johnson synthetic surgical transvaginal mesh used to treat pelvic organ prolapse, and the Allergan Lap-Band for weight reduction because of a growing number of patient injuries and a fear that device makers and the U. S. Food and Drug Administration (FDA) may not
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Consumers Union’s Safe Patient Project Brings Eight Activists to Congress

Feb 6th, 2012 | By
CU's Safe Patient Project

February 6, 2012 ~ Consumers Union is bringing eight patient activists to Washington, D.C. to meet with lawmakers and press for strengthened medical device oversight. The timing is important. The Food and Drug Administration’s budget will be determined by the Medical Device User Fee Act (MDUFA) and the medical device industry is pushing for faster
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Showdown in House Hearings Over Mesh, Medical Devices

Jan 24th, 2012 | By
Allergan Lap-Band video

January 23, 2012 ~ House Democrats are asking Republicans for a hearing on Johnson & Johnson synthetic surgical transvaginal mesh used to treat pelvic organ prolapse, and the Allergan Lap-Band for weight reduction because of a growing number of patient injuries and a fear that device makers and the U. S. Food and Drug Administration
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