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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Category Archives: New and Social Media
It is not news that social media has fundamentally changed the way we communicate. Today, we share news, we don’t just read it. A news cycle is every moment of every day. We rely on people to pitch news to … Continue reading →
Got Google News Alerts set up? A few weeks ago I wrote a posting about the pending shut down of Google Reader that was scheduled (and happened) after July 1. I noted that it was time for people who, like … Continue reading →
Some Digital and Social Media Guidance – FDA Regulation of Pharma Communications in a Digital Era – A White Paper
I have been working to assemble a data base of FDA/OPDP Warning and NOV letters spanning the years 2004-present, tracking activity through a number of fields. The database now includes hundreds of letters and covers nearly 1000 violations cited by … Continue reading →
The Food and Drug Law Institute held its annual conference on Advertising and Promotion for the Pharmaceutical, Medical Device, Biologic and Veterinary Medicine Industries in Washington, D.C. on October 1 and 2. I was able to attend sporadically and participated … Continue reading →
Using the occasion of the announcement by Twitter that it has rebuilt its i-Pad app “from the ground up” to provide an update to last week’s posting on FDA’s twitter feeds and their influence as measured by Kred. Assessing influence … Continue reading →