About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
Monthly Archives: May 2006
Must Congress Bail the FDA Out of Deep Water?
When looking over the history of the FDA, change has generally not come from within. As an agency, it requires laws to provide it with authority to issue regulations. It can only change within the parameters it is authorized. Given … Continue reading
The FDA’s New Initiative for Medical Devices – Hidden Under a Bush
The FDA announced yesterday a Medical Device Innovation Initiative (MDII) reflective of the Critical Path Initiative and designed to act as a catalyst to speed advancements and innovation with the device industry. As pointed out in a recent speech by … Continue reading
Posted in Current Affairs, FDA Image, FDA Policy
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A New Resource on Warning Letters
As part of my quarterly review of Warning Letters, I will provide an summary overview of all the DDMAC Warning Letters issued. The purpose is to provide a "look back" for those responsible for communications that can be a useful … Continue reading
Posted in Useful Resources
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Stem Cell Research – a Vehicle for Running Away from Bush?
I am sorry to ditch the Weekly Roundup for a second week in a row, but when something catches my eye that I can’t resist, the Roundup has to go…. This week, Senate Majority Leader Bill Frist is reportedly determined … Continue reading
Posted in Current Affairs
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Clouds on the Horizon, Part III
Back on April 7, in the posting Clouds on the Horizon, Part I, I wrote about Medicare Part D and the impending donut hole. For those of you who don’t remember, or are new to the blog, the donut hole … Continue reading
Posted in Pharma Industry Image, Pricing and Value
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