MDUFA

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FDA Follows Industry Lead to Shorten Time to Market

October 30, 2012 ~    The FDA has issued the new rules for medical device makers to speed up the time it takes for medical devices to make it to market. Earlier this year industry agreed to pay $595 million over 5 years to the FDA as part of its Read more

By | 2012-10-31T00:27:06+00:00 October 31st, 2012|FDA News|1 Comment

FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

Dr. Jeffrey Shuren, CDRH If you ask the public, most say they want safer medical devices, not more of them.  If you ask the patients profiled in Mesh Device News Desk (MDND) they’d say they wished they’d known that the medical devices they received had come with a Read more

By | 2012-06-14T15:58:11+00:00 June 14th, 2012|FDA News|1 Comment

Senate Passes FDA Funding Bill Minus Major Patient Safety Provisions

May 24, 2012 ~ The U.S. Food and Drug Administration (FDA) is one step closer to being funded for the next five years in a bi-partisan vote considered good for the FDA and industry – but what about patients? The Food and Drug Administration Safety and Innovation Act passed on Read more

By | 2012-05-24T23:15:39+00:00 May 24th, 2012|FDA News|2 Comments

Politico Ad: Consumers Union Warns the FDA Cannot Protect Patients

May 22, 2012 ~ The U.S. Food and Drug Administration (FDA) has as its mission the protection of the American people from dangerous consumer products such as food, pharmaceuticals and medical devices – right? Consumers Union in a recent poll found most Americans  believe safety is the FDA’s Read more

By | 2012-05-22T18:30:12+00:00 May 22nd, 2012|Featured|1 Comment

FDA Closer to Funding Goals – Where is Patient Safety?

On May Tuesday, May 8, a House subcommittee unanimously voted to approve its version of the Medical Device User Fee Act (MDUFA) which funds the U.S. Food and Drug Administration’s oversight of medical devices for the next five years. However, the House voted 46-0 without approving legislation that Read more

By | 2012-05-14T21:18:41+00:00 May 14th, 2012|FDA News|2 Comments

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

Must Watch Live Feed: Hearings on Mesh, Medical Device Budget Pits Patient Safety v. Industry

A must watch show How to Watch:  Go to www.energycommerce.house.gov  (link will show up when gavel begins hearing, live feed)  Hearing: "Reauthorization of MDUFA: What It Means for Jobs, Innovation and Patients" When: The Subcommittee on Health has scheduled a hearing on Wednesday, February 15, 2012, at 10:00 a.m. in Read more

By | 2012-02-13T13:43:07+00:00 February 13th, 2012|Featured|1 Comment

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
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