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.Stay Connected
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I 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: April 2006
Weekly Roundup
A New and Regular Feature – I’ve decided to use Friday’s as a time to round up the small news, stuff you might not have been able to notice, or if you did, to think about much. New Appointment at … Continue reading
Posted in Weekly Roundup
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Warning Letter Summary for First Quarter 2006
After the end of each quarter, I would like to make it a point to review the FDA Warning Letters issued from DDMAC and describe the nature of the letters and the violations. The point will be (i) to highlight … Continue reading
Posted in Warning Letters
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100 Years of Fortitude
The FDA is celebrating its 100th birthday. Like the FDA’s Critical Path Initiative (CPI) (see prior posting on this topic), this is an opportunity to get some messaging out there to support the agency. However like the CPI, it appears … Continue reading
Posted in FDA Image
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The Bio Conference and the FDA Survey
The BIO conference was held last week in the wonderful city of Chicago. A lot of people have been writing about it. So I decided to join in. The blog On Pharma has some very nice daily updates. Former President … Continue reading
Posted in Biologics, FDA Policy
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Avoiding a Crisis in Communications during a Medical Product Crisis
Looking back over the week, one of the events of note was the issuance of an alert by FDA that warned contact lens wearers of the possibility of fusarium keratitis, a fungal infection that can occur in the eye and … Continue reading
Posted in Crisis Communications, Pharma Industry Image
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