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. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
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 Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York 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: November 2006
Tutorial on FDA Approval Outcomes
Every so often, I think it is a good idea to make sure everyone is on the same page for terminology and what it means. Therefore, today I’m reviewing a few terms and situations. If you are already knowledgeable about … Continue reading
Posted in Tutorial 5 Comments
What’s the Track Record on the Fast Track? – Part 1
I thought it a good idea to take a look back at the Fast Track status and get an idea of what the trends have been in this all important category. Though the chart below is copied from the CDER … Continue reading
Posted in FDA Policy Comments Off on What’s the Track Record on the Fast Track? – Part 1
PDUFA Fees to Raise Money for Ad Reviews
And now, for a commercial break. At the precipice of the Congressional turnover, the FDA has reached a tentative agreement regarding the review by the agency of television commercials. According to the Wall Street Journal last week, pharmaceutical companies would … Continue reading
Posted in DTC Advertising, PDUFA 2 Comments
Medicare Part D – If it Ain’t Broke, Don’t Fix It
Every so often, unlike some of the more partisan of those in my field, I have to admit when I might be wrong. It hurts doing it, but afterward, I always feel better. Plus, you have the added benefit of … Continue reading
Posted in Current Affairs Comments Off on Medicare Part D – If it Ain’t Broke, Don’t Fix It
Hello everyone. I’m taking the rest of the holiday week off so Eye on FDA will be on hiatus until Monday. Have a wonderful holiday.
Posted in Current Affairs Comments Off on Happy Thanksgiving