About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in Washington D.C. 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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Last week Commissioner Scott Gottlieb delivered remarks at the Health Datapalooza, the meeting representing a nexus between innovation in digital health and the world of policy. He began his talk by saying that for most of the last century, medical … Continue reading
FDA has had a lot to say so far this year. A real lot. In fact, during the first three months of 2018, FDA issued 56 press releases, which is as many as they issued during the entire first half … Continue reading
Keeping our eye on FDA press releases as one measure of the way FDA talks to us is a regular feature here on Eye on FDA and there is no better time to look back than when we begin a … Continue reading
As we begin the new year, it is time toassess the previous year and consider what really mattered when all is said and done. We’ve perhaps already done this on a personal level, but here is my take on an … Continue reading