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On the Road with Stephen Rapundalo
With Lilly CEO John Lechleiter

June ended with a visit to The Henry Ford Innovation Institute where I caught up with Stephen Bartol, MD, Chief Medical Officer, Innovations and Mark Coticchia, Vice President and Chief Innovation Officer. They updated me on the fantastic work going at the Institute including the creation of a fellowship program to develop leaders empowered to address health care technology challenges through innovative solutions and entrepreneurial approaches. [Read more 'On the Road']

Registration is open!
This first-year symposium will showcase drug R&D activities at the state's research universities and discuss the development, funding, partnering, and commercialization of new therapeutic discoveries. Presented by MichBio and the University Research Corridor; hosted by Michigan State University.
21st Century Cures Act Passes House
In a rare act of bipartisanship the U.S. House voted 344-77 on July 2 in favor of the act, which supporters say will speed the development and regulatory approval of medical breakthroughs. Critics say that speed would come at the expense of patients' safety. [More]

MichBio Advocates to Protect Patent Rights, Oppose H.R. 9
MichBio is opposing the Innovation Act that would threaten the ability of innovative bioscience companies to enforce their patents and fund continued R&D. [More]

Federal Right to Try Act Introduced
The bill, introduced in the U.S. House of Representatives, seeks to expand the access of terminally ill patients to experimental drugs in a novel way, by prohibiting the federal government, including FDA and DEA, from taking action to stop such access. [More]

FDA Device Accountability Act
The bipartisan legislation means to re-introduce and strengthen the "Least Burdensome" provisions of the current law to require faster, less burdensome product clearances and approvals. [More]

White House to Update Biotechnology Framework
The White House Office of Science and Technology Policy directed the FDA, USDA, and EPA to "improve the transparency, predictability, coordination, and, ultimately, efficiency of the biotechnology regulatory system." [More]

Final Guidance on Planned Exemption of Certain Devices
This guidance describes the agency's intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices from premarket notification requirements. [More]

Draft Guidance on UDI Direct Marking of Devices
This document is intended to help medical device labelers and FDA staff understand the FDA's requirements for direct marking of devices for unique device identification purposes. [More]

Draft Guidance Issued on Factors to Consider When Making Benefit-Risk Determinations for IDEs
The proposed rules further the agency's efforts to balance risks and benefits with respect to approving medical devices through the premarket approval (PMA) pathway or utilizing the de novo classification process.
MD&M Philadelphia
Members save 20% off registration and receive free expo admission; sign-in for promo code.
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