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: July 2009
There has been a good deal of talk coming out of the FDA these days about improving transparency. For example, there has been set up a Transparency Task Force, and on June 24, the FDA held a Transparency Meeting which … Continue reading
As if it were needed, yesterday one more example emerged yesterday to demonstrate how the FDA is failing in the all important digital space. The National Institutes of Health announced a collaboration with the Wikimedia Foundation that has the aim … Continue reading
There are a number of angles that one can look at the FDA to see if there are indeed winds of change blowing through the agency. Recently, we looked at the level of warning and untitled letters coming out of … Continue reading
In May 2007, the FDA responded to an increasingly vocal set of critics in Congress by appointing Dr. David Acheson at FDA to "Assistant Commissioner for Food Safety" – with the media quickly dubbing him as the new "food safety … Continue reading
Yesterday we examined the quantitative aspect of the warning and untitled letters from FDA's DDMAC – today we are going to look at the substance of the letters to discern any lessons learned. And just for the record, the … Continue reading