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: September 2007
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
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
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
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
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