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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Monthly Archives: September 2016
Weekly Roundup 9.30.16
The shifting of gears is happening before our eyes. Already leaves are falling and the morning alarm goes off in the final moments of night time darkness rather than the first rays of morning sunshine. The trees are signalling that … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 9.30.16
Breakthrough Therapy Status, AdComms and Approvals
In recent years FDA has undertaken several means to facilitate the consideration of new drug applications by creating various mechanisms for expedited review for either new drugs or new indications for existing drugs. Prior to 2012, there had long been … Continue reading
Posted in Advisory Committee Prepapartion, FDA Policy 1 Comment
Weekly Roundup 9.16.16
Kids are back in school. The air is kinder, gentler and less harsh than the last heated days of summer, though summer tries to hang on some days, it is ebbing into Autumn. Halloween candy has already appeared in stores. … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 9.16.16
Weekly Roundup 9-2-16
The end of summer. This is less like a Weekly Roundup than a Monthly Roundup. Like everyone else, I have taken August with a grain of salt. It feels a little lonely writing blog postings when you know that readers … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 9-2-16