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: April 2009
The Increasing Utility of Twitter
While the regulatory side of new media has been muddled by recent FDA contradictions in what it says and what it does, the media themselves continue to develop. Twitter, in particular, has enjoyed both growth and high visibility. And, not … Continue reading
Posted in New and Social Media
1 Comment
Obama Administration Shifts Agency Gears on Safety – What Does it Mean for Food and What Does it Mean for Drugs
There have been a lot of changes at the FDA in the past few weeks – changes in personnel and changes in approach. Today the New York Times reports that Dr. Joshua Sharfstein, who has taken the reigns as Acting … Continue reading
Posted in Food, Risk Management
Comments Off on Obama Administration Shifts Agency Gears on Safety – What Does it Mean for Food and What Does it Mean for Drugs
14 Warning Letters in a Day! What’s That About?
Last week, FDA's DDMAC issued a whopping 14 Untitled Letters in a single day. It is a good thing they did not do it on April 1 – no one would have believed it. That number of letters, issued in … Continue reading
Posted in FDA Policy, Warning Letters
6 Comments