patient safety

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FDA Helps Industry Push Medical Device Innovation

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 Read more

By | 2012-12-04T20:45:09+00:00 December 4th, 2012|FDA News|1 Comment

Michigan Lawmaker Wants FDA Promoting Jobs, Industry

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 Read more

By | 2012-04-20T01:12:49+00:00 April 20th, 2012|FDA News|2 Comments

FDA: What is MDUFA? Hearings on $595 Million and What Industry Wants

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 Read more

By | 2012-02-14T20:20:15+00:00 February 14th, 2012|FDA News|0 Comments

Call to Action – House Energy & Commerce Committee Hearings on Mesh

  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. Read more

By | 2012-02-12T20:45:29+00:00 February 12th, 2012|Op-Ed|0 Comments

Consumers Union's Safe Patient Project Brings Eight Activists to Congress

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 Read more

By | 2012-02-06T21:34:14+00:00 February 6th, 2012|Featured|0 Comments

Showdown in House Hearings Over Mesh, Medical Devices

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 Read more

By | 2012-01-24T18:10:01+00:00 January 24th, 2012|Media Reports|4 Comments