About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in Washington D.C. 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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Category Archives: Generic Drugs
FDA apparently intends to implement today an idea that has been kicking around for a while to begin publishing the names of companies that have had letters of complaint lodged against them asserting that they are taking actions to block … Continue reading
A month ago I was able to sit down with FDA's Deputy Commissioner Dr. Joshua Sharfstein to discuss the FDA's new effort at transparency and accountability called FDA Tracker, resulting in a podcast on the subject. FDA Tracker is a … Continue reading
No doubt the latest report from the Federal Trade Commission (FTC) Bureau of Competition is going to set the hair of several congresspeople on fire and will perhaps result in a hearing on the matter. The subject of the report … Continue reading
Yesterday the FDA issued a news release that was entitled the "Critical Path Opportunities for Generic Drugs" that raises more than a few interesting points. First, it has been a long time since we’ve heard much about the FDA’s Critical … Continue reading
Lately the environment for generic drugs has grown much warmer. Consider, last week the FDA/CDER proposed a speedier process for considering approval of generics. Walmart, one of the biggest retail chains in the country, announced it would sell many generics … Continue reading