AZBio uses StateNet from Lexis Nexis to stay up to date on what is happening on Capitol Hill and across the 50 states. To get the latest news, delivered to your email mailbox, get your complimentary subscription at StateNet.com or read the copy on-line here.Continue reading
Category Archives: Government Affairs Blog
Tips on Writing Powerful Public Comment Letters Regarding Proposed Regulations
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
The FDA When There’s An App For That
There is a lot happening on the medical device front these days around MDDS (Medical Device Data Systems) and the FDA is paying close attention with new regulations, guidance and requests for comment.
With the April 2012 compliance deadline less than 8 months away, AZBio Member John C. Hoffman of QMR is paying close attention too and keeping our community in the loop via the AZBio Resource Network Group on LinkedIn. If you and your team are working in the MDDS space, you’ll want to get connected and join the discussion.
The Latest from the Capitol – 08 15 2011
AZBio uses StateNet from Lexis Nexis to stay up to date on what is happening on Capitol Hill and across the 50 states. To get the latest news, delivered to your email mailbox, get your complimentary subscription at StateNet.com or read the copy on-line here.Continue reading
AZBio shares information on Medicare Part D
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
The Latest from the Capitol 08 08 2011
AZBio uses StateNet from Lexis Nexis to stay up to date on what is happening on Capitol Hill and across the 50 states. To get the latest news, delivered to your email mailbox, get your complimentary subscription at StateNet.com or read the copy on-line here. Continue reading
Advocacy groups launch IPAB watch
AZBIO Washington Watch
Several minority organizations and disease advocacy groups are starting a website to track concerns about and opposition to the Independent Payment Advisory Board.Continue reading
BIO Unveils Strategic Initiative to Speed Scientific Breakthroughs, Develop Cures and Grow the Bio-Economy
“Unleashing the Promise of Biotechnology: Advancing American Innovation to Cure Disease and Save Lives” Provides Roadmap for Transformative Policy Changes
WASHINGTON, D.C. (Wednesday, June 29, 2011) – The Biotechnology Industry Organization (BIO) released today a summary of legislative proposals to reform the investment and regulatory environment for biotech innovation. These proposals are designed to unleash the innovation required to cure disease and make the U.S. healthcare system more affordable, efficient, and of higher quality, as well as to foster the development of breakthrough technologies to provide alternative energy sources, combat hunger and protect against bio-terrorism. The policy proposals, released at a press briefing at the 2011 BIO International Convention held here this week, will serve as the organization’s targeted advocacy plan in these two areas.
Washington Watch: the debt ceiling and deficit debate in DC
There has been a lot of talk about budgets and debt ceilings in Washington this week. The negotiations – now taking place between the President and Congressional leaders are fluid, closely held, and difficult to predict. It does not take a PhD to know that Medicare and Medicaid cuts are on the table.
At AZBIO we stay in close communication with our partners at BIO, PhRMA, and AdvaMed so that we can share the latest news with our members.Continue reading
BIO Praises House Passage of Patent Reform Legislation
Press Release from BIO: The Leahy-Smith America Invents Act will benefit all sectors of U.S. economy
Washington, D.C. (June 23, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on the passage of The Leahy-Smith America Invents Act, H.R. 1249, by the House of Representatives:
“Small biotechnology companies rely heavily on their patents to attract investment to fund the lengthy and expensive research and development process necessary to bring breakthrough medical therapies and other products to patients and consumers. Strong intellectual property protection is critical for these companies.
“The Leahy-Smith America Invents Act will bring our patent system into the 21st century. The improvements made by the bill will benefit all sectors of the national economy by enhancing patent quality and the efficiency, objectivity, predictability and transparency of the U.S. patent system.