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: September 2007
Weekly Roundup 9-21-07
Goodness, we are on the edge of the first day of Fall which will occur on Sunday. Where, one asks, did the summer go? Tanlines are beginning to fade, sweet potato vines are beginning to pull back, and mums are … Continue reading
Posted in Weekly Roundup
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PDUFA IV
As we all wait anxiously for Congress to do its job and actually produce legislation for signature, and as many FDA employees see their jobs hanging in the balance while awaiting PDUFA IV, some may wonder what it is all … Continue reading
Posted in Proposed Legislation
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Receipe for Reform – Is Food the Next Frontier?
An Associated Press story today entitled "Government Never Improved Produce Inspections After Deadly E-Coli Outbreak" discusses the current state of food inspections, particularly leafy greens. According to the article: "AP’s review of data obtained through the federal Freedom of Information … Continue reading
Posted in Food
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This is Your State – This is Your State on Drugs – An Intermittent Series
I’m a bit late on this update, which came out late last month, but the National Conference of State Legislatures has released another overview of what states are doing in legislation so far this year in healthcare. Here are a … Continue reading
Posted in Legislation
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A Conversation with Pill Book Editor – Dr. Harold Silverman
I had occasion to have a conversation with Dr. Harold Silverman, editor of The Pill Book – a perennially popular resource for consumers to learn about the medicines they are taking, now in its 12th edition. We of course talked … Continue reading