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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Category Archives: Podcast
Perspectives on the Drug Shortage Issue
The issue of drug shortages has surfaced periodically in the news and in policy circles for months, prompting both FDA and the Administration to various actions. For some, it may be an abstract notion – the idea that some drugs … Continue reading
Posted in Current Affairs, Podcast 1 Comment
Let the Sunshine Part 3 – Taking it on the Road: Transparency Outside the U.S.
The past two days have been focused on The Physician Payment Sunshine provisions of the Patient Protection Affordable Care Act in the U.S. which will require the reporting of financial relationships between medical product manufacturers and medical providers by 2013. … Continue reading
Posted in Pharma Industry Image, Podcast Comments Off on Let the Sunshine Part 3 – Taking it on the Road: Transparency Outside the U.S.
Status of FDA’s Proposed Regulations on Menu Labeling – A Conversation
Last Friday, the FDA published notice about draft guidance on the issue of menu labeling in restaurants. The idea of labeling food choices in restaurants has long been a goal of those who advocate for greater education for consumers in … Continue reading
Posted in FDA Policy, Food, Podcast, Uncategorized Comments Off on Status of FDA’s Proposed Regulations on Menu Labeling – A Conversation
The U.S. Pharmacopeia – What is it? What Does it Do?
One of the most frequent searches I see that people perform when coming to Eye on FDA is this – "Are Canadian Drugs Safe"? And safety, in this day and age, is the name of the game. As I've … Continue reading