MichBio to Host FDA Commissioner - your input is needed!

06/30/2010

On July 9, MichBio will host the FDA Commissioner, Dr. Margaret Hamburg, in Ann Arbor for an informal CEO Forum. This event will be a unique opportunity for MichBio and a small group of industry leaders (by invitation only) to discuss relevant regulatory issues with Dr. Hamburg. It is imperative that the FDA hear industry viewpoints as it continues to evolve changes to its regulations that will likely impact companies R&D, manufacturing and marketing activities.

We are soliciting opinions from as broad a cross-section of our membership as possible (devices, pharma, diagnostics, food, etc.), since the forum cannot accommodate large participation. We would appreciate greatly your thoughts and experiences on issues related to the FDA - e.g., product approval processes, manufacturing compliance regulations, post-market reporting and safety, and other oversight topics.

Please direct your comments to Stephen Rapundalo, President and CEO, by no later than Wednesday July 7 at srapundalo@michbio.org or by calling (734) 476-0648. MichBio will compile this information and use it on July 9th.