About the Author
My 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.Stay Connected
My Profile
I 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.
Posts by Date
October 2023 M T W T F S S 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Twitter List
Legislative Tracking Tools
Category Archives: Useful Resources
Principles for COVID-19 Healthcare Communications – 1 Keep it Simple, Keep it Organized
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
Posted in Business/Industry News, Crisis Communications, Current Affairs, Useful Resources
Comments Off on Principles for COVID-19 Healthcare Communications – 1 Keep it Simple, Keep it Organized
Freshman Healthbook
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
Posted in Useful Resources
2 Comments
Healthcare and the Election – Stateside Ballot Initiatives
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
Posted in Proposed Legislation, Useful Resources
Comments Off on Healthcare and the Election – Stateside Ballot Initiatives
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
Posted in Useful Resources
Comments Off on FDA Untitled Letter for a Sponsored Link and a Webinar: In More than 140 Characters: FDA’s Social Media Guidance – Past, Present and Future
FDA Press Releases – What They Say – First Half 2014
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
Posted in Useful Resources
Comments Off on FDA Press Releases – What They Say – First Half 2014