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.
Monthly Archives: January 2011
Health Claims and Food – GAO Issues a Report – FDA Needs to Clarify
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
Posted in Food, Uncategorized
2 Comments
New Diabetes Blog Launched by sanofi-aventis U.S.
While the pharmaceutical industry has increasingly jumped into Twitter (with about 66 feeds or so from 28 companies), some of which are feeds that are disease-specific, and an increasing willingness to explore Facebook, when it comes to the medium of … Continue reading
Posted in New and Social Media
2 Comments
Practical Need-to-Know Tips About Changes to AdComm Preparations
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
Posted in Advisory Committee Prepapartion
1 Comment
Warning Letter Summary 4th Quarter 2010 – Part 1
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
Posted in Warning Letters
2 Comments
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
Posted in Food, Legislation
8 Comments