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.
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Category Archives: Approvable Letters
By my accounting, the FDA has just issued its fourth approvable letter so far in 2008. Compare that to 2007 when by this date, the agency had issued a whopping 12 approvable letters. And, according to an article carried on … Continue reading
This time, the letter was directed to Astellas, and it isn’t the first one. According to an Astellas press release that was issued today, the company stated that it received an approvable letter for its NDA for FK 506 Modified … Continue reading
Basilea Pharmaceutica announced today that the FDA has issued an approvable letter for its first-in-class anti-MRSA agent cephalosporin for which company sought an indication to treat skin infections and diabetic foot infections. According to the company, prior to approval the … Continue reading
I finally did it! I have updated the listing of Approvable Letters that is housed in the left column of the blog under Resources by Me. I now have all of the approvable letters listed that I have seen occur. … Continue reading