FDA

Senate Passes FDA Funding Bill Minus Major Patient Safety Provisions

May 24th, 2012 | By
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 an unusual bi-partisan vote,  96-1,
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FDA Closer to Funding Goals – Where is Patient Safety?

May 14th, 2012 | By
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 would protect Americans from defective medical devices
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Michigan Lawmaker Wants FDA Promoting Jobs, Industry

Apr 20th, 2012 | By
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 jobs promotion and growth for industry, a
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FDA Expert Panel to Assess Metal Hips

Mar 30th, 2012 | By
FDA Expert Panel to Assess Metal Hips

The FDA has scheduled a two-day expert panel review of metal-on-metal hips as concerns mount about patient injuries. The June 27-28 gathering (location yet to be announced) will include researchers, patients, doctors and scientists to decide whether or not the agency needs to do a better job protecting patients in light of the high complication
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Johnson & Johnson Began Phasing out DePuy Defective Hip Prior to Recall

Mar 23rd, 2012 | By
Johnson & Johnson Began Phasing out DePuy Defective Hip Prior to Recall

March 23, 2012 ~ This has not been a good week for Johnson & Johnson. First word that it sold the transvaginal surgical mesh, ProLift, without getting any sort of FDA approval in advance (see background story here). Now the New York Times (NYT) (here) is reporting that J&J began phasing out the DePuy defective
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Survey: Despite Progress, FDA Scientists Feel Political and Industry Pressure

Mar 14th, 2012 | By
Survey: Despite Progress, FDA Scientists Feel Political and Industry Pressure

March 7, 2012 ~ The Union of Concerned Scientists (USC) issued the results of a survey released today of 977 Food and Drug Administration scientists. They were asked about the pressure they feel to approve drugs and medical devices – can they communicate candidly with the public? – can they publish their results? –  is
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Australia’s Version of FDA Lax on Medical Device Safety

Mar 6th, 2012 | By
Australia’s Version of FDA Lax on Medical Device Safety

With the global news about the defective French breast implants called PIP filled with industrial silicone, the Canberra Times (here), published in the capital city of Australia, takes a look at how medical devices reach the market there. Australia’s version of the U.S. Food and Drug Administration (FDA) is called the Therapeutic Goods Administration (TGA)
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FDA: What is MDUFA? Hearings on $595 Million and What Industry Wants

Feb 14th, 2012 | By
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 funded about 20 percent of the medical
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Where Are the Postmarket Surveillance Plans for POP, SUI Mesh?

Feb 14th, 2012 | By
Where Are the Postmarket Surveillance Plans for POP, SUI Mesh?

February 14, 2012 ~ Where’s the Plan? On January 3, 2012, the FDA sent out copies of a 522 order to 33 manufacturers of synthetic surgical mesh for pelvic organ prolapse and 7 manufacturers of mesh for stress urinary incontinence. Here is the background story on MDND. The request says, “Within 30 days of receipt
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Mesh Makers Who Received FDA Letter Requiring Postmarket Surveillance

Jan 9th, 2012 | By
Mesh Makers Who Received FDA Letter Requiring Postmarket Surveillance

JANUARY 9, 2012 ~ The following is a list of the companies who received the letters from the Food and Drug Administration (FDA) January 3, 2012, requesting three years of followup studies on the complications associated with synthetic surgical mesh used for pelvic organ prolapse and stress urinary incontinence. This is unprecedented in that the
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.