Understanding the issues facing your company or industry is critical to anticipating and alleviating business risk. To assist you, Ernst and Young offers two Smoke Detector® Reports that can help you quickly identify new legislative, regulatory and legal news affecting your business. One report monitors the life sciences industry and the other focuses on corporate compliance.
Category Archives: Advocacy and Regulations
State Net Capitol Journal for 01 23 2012
AZBio partners with LexisNexis and State Net to bring you all the latest updates from Washington DC and around the nation. Check out the latest in the January 23, 2012 edition.
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State Net Capitol Journal for 01 16 2012
AZBio partners with LexisNexis and State Net to bring you all the latest updates from Washington DC and around the nation. Check out the latest in the January 16, 2012 edition.Continue reading
FDA releases draft guidance on medical device applications
The Food and Drug Administration unveiled draft guidance Wednesday on how it reviews applications for low-risk medical devices under the 510(k) program and is requesting industry comment.
State Net Capitol Journal for 12 19 2011
AZBio partners with LexisNexis and State Net to bring you all the latest updates from Washington DC and around the nation. Check out the latest in the December 19, 2011 edition.Continue reading
SBIR and STTR Reauthorized for Six Years
Today the SBIR was reauthorized for a period of 6 years, ending September 30, 2017. This includes STTR, and what was the Commercialization Pilot Program (CPP), now to be known as the Commercialization Readiness Program (CRP). The reauthorization was included in the National Defense Authorization Act of 2012 (NDAA) HR.1540.
The bill has been sent to the President to sign the bill into law, and he has said he would.Continue reading
Opportunity to comment on new reporting rule at CMS
| For Immediate Release: | Wednesday, December 14, 2011 |
| Contact: | CMS Office of Public Affairs 202-690-6145 |
AFFORDABLE CARE ACT SUNSHINE;
RULE INCREASES TRANSPARENCY IN HEALTH CARE
The Centers for Medicare & Medicaid Services (CMS ) announced today a proposed rule that will increase public awareness of financial relationships between drug and device manufacturers and certain health care providers. This is one of many steps under the Affordable Care Act designed to increase transparency in the health care system, which can lead to better care at lower costs.Continue reading
One step closer on the road to SBIR Reauthorization
The SBIR/STTR program has not been reauthorized yet but we are one step closer as the December 16th deadline approaches.
Monday (December 12, 2012) word of a Senate/House compromise was announced that may lead to a positive outcome that would reauthorize the SBIR/STTR program for six years. This would be a huge improvement over the multiple short term extensions we have seen in recent years. Continue reading
Making Sense of the Medical Device Tax
Estimated at $20B, the Medial Device Tax was included in the Affordable Care Act that was signed into law by President Obama in 2010. The amount is based on a 2.3% excise tax that will be levied on the total revenues of a company, regardless of whether a company generates a profit, starting in 2013.
While many industry groups including AZBio, AdvaMed, and MDMA have been sharing information on why this tax is unwise and have worked to explain the negative effects that it could have on innovation and patient care, there is always the possibility that it will not be repealed before 2013.
Ernst and Young recently published a Tax Note on the Medical Device Tax that gives a comprehensive overview of what it is, who it affects and how they will be affected. The tax note is provided below as published by E&Y and is shared with permission.Continue reading
AZBio Celebrates Trailblazers
Arizona’s bioscience community came together on December 1, 2011 to show appreciation to the leaders who have blazed the path for bioscience growth here in Arizona. We call these individuals “Trailblazers.”
Members of community from across the state had an opportunity to share ideas with legislators, elected officials and leaders from Arizona’s bioscience companies, universities and research institutions. AZBio members also were updated on the latest results from the AZBio Viewpoint Survey and all attendees received the 2012 AZBio public policy initiatives as well as a comprehensive list of policy recommendations from the Flinn Foundation and the Bioscience Road Map Steering Committee. Continue reading