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.
Posts by Date
Monthly Archives: January 2011
Last week, the General Accounting Office issued a report entitled “FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims” where – well, the title sort of gives away the gist of the thing, doesn’t it. FDA does need to … Continue reading
The FDA has been settling into their new digs in Montgomery Maryland called White Oak, and the move of such a large agency into a new facility has been a process, not an event, as one might imagine. The old … Continue reading
Warning letters and NOV letters from DDMAC have a rather irregular cycle of posting to the FDA/DDMAC Web site. Some of the letters are posted the very day they are sent, others are not posted for days, sometimes weeks afterwards. … Continue reading
Food Safety Modernization Act – Passed but Not Funded – A Conversation with Congressman Jack Kingston of the House Appropriations Committee
Many were surprised when at the end of the 111th Congress, the Food Safety Modernization Act was passed and in early January, President Obama signed it into law. FDA Commissioner Margaret Hamburg was a key proponent of the bill, and … Continue reading