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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Monthly Archives: March 2011
As many might have guessed, the second target date set by FDA’s DDMAC for the issuance of a Draft Guidance on Social Media and the Internet is about to pass, apparently without any new developments. Slated for the end of … Continue reading
When the Affordable Patient Care Act (more commonly known as Health Care Reform) became the law of the land, it had several provisions in it that charged the FDA with very particular tasks as part of the implementation of the … Continue reading
Congress has been gone this week which has made the local commute quite bearable, though one has to wonder how they could all take off when they haven’t finished a budget for this fiscal year. Spring here is being threatened … Continue reading
For many years now, there has been a long wait after a public hearing held in 1996 on some form of guidance from the FDA that would provide communications guidelines for this new medium. Fifteen years have passed and those … Continue reading
The trio of tragedies that hit Japan are now spawning a fourth – the potential for radioactive contamination of food and water. There are now reports that the FDA has banned food imports from four prefectures – those located closest … Continue reading