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: July 2010
FDA Advances in Social Media – What’s it Mean for Industry?
Greetings from the 6th Annual PR & Communications ExL Pharma Summit being held in the headquarters of Pfizer in New York, yesterday and today. One of the highlights of the two-day meeting occurred this morning when CDER's head of … Continue reading
Posted in Uncategorized 2 Comments
What is PDUFA?
I used to have a much beloved co-worker who was not in healthcare, but upon hearing the term "PDUFA" – standing for the Prescription Drug User Fee Act – for the first time during a meeting, shouted out "What the … Continue reading
Posted in PDUFA, Tutorial 2 Comments
New Drug Proposed for FDA Regulation of Cosmetics
Recently there have been a number of new laws proposed or enacted aimed at giving the FDA more authority over both food and drugs. However, another area (often overlooked) of regulatory authority is cosmetics. This week, however, cosmetics takes on … Continue reading
Posted in Legislation 1 Comment
Disclosure, Disclosure, Disclosure – Advisory Committee Conflicts of Interest
With real estate of course, it is location, location, location. With government functionaries these days though, the key word is about disclosure. Fierce Biotech carried a nice overview of the recent situation that arose in the wake of the … Continue reading
Posted in Uncategorized Comments Off on Disclosure, Disclosure, Disclosure – Advisory Committee Conflicts of Interest
PharmaBook – Facebook and Pharma
When social media began to ebb from a media pathway for individuals to connect, to one where institutions and industry began to employ social media as a means of communicating with their constituencies, the pharmaceutical industry, as a highly regulated … Continue reading
Posted in Uncategorized 3 Comments