Category Archives: Advocacy and Regulations

AZBio Comments on the FDA 510K

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 as submitted to the FDA on September 23, 2011

RE: Docket No. FDA-2011-N-0556

[Center for Devices and Radiological Health 510(k) Clearance Process; Institute of Medicine Report: “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years”; Request for Comments]
 

On behalf of the Arizona BioIndustry Association (AZBIO), I appreciate the opportunity to submit  comments to the Food and Drug Administration’s (FDA’s) Center for Devices and  Radiological Health (CDRH) on the Institute of Medicine’s (IOM’s) report,  “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at  35 Years” (Docket No. FDA-2011-N-0556).Continue reading→

Study: Medical Device Tax Could Cost Jobs, Stifle Innovation

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WASHINGTON,D.C. –The medical device tax, if implemented, could cost tens of thousands of jobs, almost double the industry’s total taxes, raise the effective tax rate to among the highest in the world, and harm U.S. competiveness, according to a study released today by the Advanced Medical Technology Association (AdvaMed).  The new study, “Employment Effects of the New Excise Tax on the Medical Device Industry,” by Manhattan Institute senior fellow Diana Furchtgott-Roth and Hudson Institute senior fellow Harold Furchtgott-Roth, outlines a number of economic harms likely to result from the tax.Continue reading→

Tips on Writing Powerful Public Comment Letters Regarding Proposed Regulations

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By: Michael T. Hull – Managing Director, InVent Life Sciences   mhull@inventls.com  (Former Regional Advocate for the U.S. SBA Office of Advocacy)

The federal government proposes and finalizes approximately 4,000 new rules every year. In general approximately 800-1,000 will directly affect small business. A 2008 study by the U.S. Small Business Administration’s Office of Advocacy estimated that the cost of complying with federal rules and regulations exceeds $1.75 trillion per year with small businesses spending approximately 36% more per employee than their large business counterparts.Continue reading→

AZBio shares information on Medicare Part D

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 as sent to members of the Arizona Congressional Delegation

August 9, 2011

Changes to Medicare Part D – Please Don’t “Fix” a System That Is Working

We have a lot of things that need fixing at the moment as the financial burden our country bears comes under further review and adjustments.  Many of our systems are broken, but some are working.  Medicare Part D is one system that works.Continue reading→