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 2006
It is Friday, and true to my developing tradition, I am going to softball it by delivering just a short and sweet message. But yesterday, FDA actually delivered a lengthy one by issuing a press release today summing up the … Continue reading
During FDA Advisory Committee meetings, there is an Open Public Comment period that is scheduled to permit concerned members of the public to comment on the issues before the advisory committee. Those who sign up are asked, in the interests … Continue reading
A big story yesterday was centered on scientists making a genetically engineered pig that when eaten, rather than producing Omega-6 into your system, brought the sought after Omega-3. Getting the benefits of salmon while eating pork chops! It’s a … Continue reading
Recall my recent posting of March 21, 2006 regarding the President’s call for more transparency in health care. Some states aren’t waiting for an answer to that call, they are moving on their own. Last month, Julie Appleby reported in … Continue reading
When state legislatures tire of waiting for federal action, they often begin to take the initiative themselves. For example, consider that while legislation has been introduced into Congress to affect the FDA Office of Drug Safety, there is legislation being … Continue reading