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 2007
The FDA has issued another approvable letter – this time to Neurochem for eprodisate (KIACTA(TM)) for the treatment of Amyloid A (AA) amyloidosis. This was not good news on two fronts – first, it was the product’s second approvable letter … Continue reading
Recently, two pharmaceutical companies announced that they would be seeking Formal Dispute Resolution (FDR) because of FDA decisions regarding their products. Genta announced in April that the company would be filing one over a non-approvable letter for their investigative product … Continue reading
As mentioned last week, I was directed by a colleague to a new blog being sponsored by GlaxoSmithKline about it’s new OTC product alli. Because this is so highly unusual, it merits a closer examination. First of all – a … Continue reading
Looking back at the week, some things just stand out. Across the country it was a hot, hot week. Triple digits nearly all over the West and wildfires breaking out in several states. There were wildfires here inside the Beltway … Continue reading