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.
Posts by Date
Legislative Tracking Tools
Monthly Archives: April 2007
The OTC Environment – A Conversation with Linda Suydam of the Consumer Healthcare Products Association
The mission of the Consumer Healthcare Products Association is to promote the increasingly vital role of over-the-counter medicines and nutritional supplements in America’s healthcare system through science, education, and advocacy. The environment for OTC products is robust. There are literally … Continue reading
Weekly Roundup – 4-27-07
Oh my gosh, who can believe it, we are almost in May! A week away in London and all of a sudden, I’ve come back to some major Spring action, with flowers blooming, my car all covered in yellow pollen … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 4-27-07
Up on the Hill – PDUFA Testimony
Last week, FDA posted a slew of testimony that was submitted before Congress. In reverse order, Steven Galson testified before the Senate Special Committee on Aging on "Bio-Identical Hormones: Sound Science or Bad Medicine" on April 19. The day before, … Continue reading
Posted in FDA Policy Comments Off on Up on the Hill – PDUFA Testimony
Post Number 300 – Blog Monitoring
Welcome to my 300th posting! Sorry about yesterday – travel back from Europe had me running to catch up. Last March when I began this blog, I wrote a posting called "What People Are Saying About You and How Do … Continue reading
The View from Abroad – A Conversation with the Pharmaceutical Correspondent of the London Financial Times
While in London, my most excellent colleague James Smith arranged for me to be able to sit down with Andrew Jack, pharmaceutical correspondent with the London Financial Times. I’m not sure correspondents like to be known as a great guy, … Continue reading
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