Washington, D.C. – The Medical Imaging & Technology Alliance (MITA), the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA) today announced that medical device manufacturers have now paid an estimated $1 billion to the Internal Revenue Service for the medical device excise tax. In reaching this threshold, the device tax has denied device manufacturers the resources that would have otherwise been available to invest in research and development (R&D), capital investments and to support good-paying jobs across America.Continue reading
Category Archives: Advocacy and Regulations
U.S. Food and Drug Administration and European Medicines Agency Reach Landmark Decisions on Critical Path institute’s Clinical Trial Simulation Tool for Alzheimer’s Disease
In a big step forward for Alzheimer’s disease (AD) therapy development, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have independently reached favorable decisions on the value of Critical Path Institute’s new disease simulation tool for improving trial design in mild and moderate Alzheimer’s disease. The first such instrument to ever receive this regulatory designation, the tool represents an enabling advance to improve the design of future clinical trials in AD. The new tool applies computerized models to simulate “what-if” scenarios for clinical trials.
The goal of this virtual tool is to serve as a public resource for sponsors designing trials of new therapies for AD.Continue reading
Expert View: FDA and 510(k)
Changes to existing medical devices 510 (k) guidelines – has the FDA gone too far?Continue reading
Congressman David Schweikert gets kudos for support of bio-entrepreneurs
The Biotechnology Industry Organization (BIO) today thanked Representative David Schweikert (R-AZ) for introducing H.R. 1952, the Spread Pricing Liquidity Act. H.R. 1952 is designed to increase liquidity and spur capital formation for small businesses, including emerging biotech companies that are traded on the public market.Continue reading
What’s up in Washington?
Read on for the latest Washington Rundown Continue reading
Congressman Gosar shares thoughts on IPAB at Medicare Today TeleTown Hall
On April 23rd, organizations from across the U.S. participated in a national tele-town hall with Representatives Matheson (D-UT) and Gosar (R-AZ) on the importance of IPAB repeal. A recording of the tele-town hall can replayed here. (Audio) Continue reading
It’s a wrap. Take aways from BIO2013
BIO2013, the 20th BIO International Convention, is one for the history books now. Let’s take a look at what was the talk of the town in Chicago.Continue reading
Congressman Ron Barber of Arizona Champions Innovation and Challenges the Medical Device Excise Tax
Rep. Barber Speaks about Tax Reform and Growing Small Businesses.
Congressman Barber’s questions focused on how specific taxes can create roadblocks for medical device manufacturers using SynCardia Systems, Inc. and the Medical Device excise tax as a great example of how our tax code can stifle creativity and innovation . Continue reading