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: May 2018
Weekly Roundup 5.25.18
It is Memorial Day Weekend! The opening bell for summer vacations has arrived. It is time to do your wardrobe switch – get out the white shoes, sandals and linen clothing and put the corduroys away until Labor Day. Time … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 5.25.18
Weekly Roundup 5.18.18
There has been so much rain in the past week, it is difficult for those of us in Washington, D.C. to remember that we live in that Washington and not Washington state. It has been relentless and it continues. It … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 5.18.18
FDA and The Scarlet Letter
FDA apparently intends to implement today an idea that has been kicking around for a while to begin publishing the names of companies that have had letters of complaint lodged against them asserting that they are taking actions to block … Continue reading
Posted in FDA Policy, Generic Drugs 1 Comment
Weekly Roundup 5.11.18
Soon school will be out, rush hour will be less hectic, vacations long planned will be taken. Pollen counts are high and thunderstorms threaten to materialize nearly every other day. Washington is moving at high speed though the gravity of … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 5.11.18