About the AuthorMy 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.
My ProfileI am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!
About This BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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Monthly Archives: October 2011
Snow is predicted for the weekend in the Northeast and there is a prediction for rain mixed with snow in our area. We haven’t even had the frost on the pumpkin yet! The leaves haven’t fallen off the trees! Madness! … Continue reading
The past two days have been focused on The Physician Payment Sunshine provisions of the Patient Protection Affordable Care Act in the U.S. which will require the reporting of financial relationships between medical product manufacturers and medical providers by 2013. … Continue reading
As noted yesterday, the Physician Payment Sunshine Act is now law, but so far, the deadline for Health and Human Services to provide guidance to medical product manufacturers on what exactly to report and how exactly to report it has … Continue reading
It may have escaped the notice of some that The Physician Payment Sunshine Act – legislation proposed that would bring greater transparency to the relationship between medical product manufacturers and medical providers – became law when the Patient Protection and … Continue reading