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.
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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On February 21 I published a piece on LinkedIn – Communications Considerations for Medical Manufacturers as the COVID-19 Epidemic Emerges – that provided an overview of some of the communications considerations for pharma, biotech and device manufacturers related to the … Continue reading
We have just been through an election cycle and the 113th Congress is in lame duck session. We are about to move on to the new Congress in January 2015. Who did America elect and what is their position on … Continue reading
We are days away from the mid-term elections. Don’t worry, this isn’t another piece to read about how the Senate could hang in the balance for weeks; or how one party or another might retain or take control of any … Continue reading
FDA Untitled Letter for a Sponsored Link and a Webinar: In More than 140 Characters: FDA’s Social Media Guidance – Past, Present and Future
I crammed a lot into that title. But here is the skinny. A few weeks ago, FDA issued some new guidances around social media. This week, (yesterday) an untitled letter was posted about a sponsored link – the subject matter … Continue reading
From time to time, I field questions centered around FDA press releases and what they say. Every time I would have to go hunt and peck through years of releases to get an answer. Eventually I just put them into … Continue reading