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.
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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Monthly Archives: February 2010
Given the dismal track record of the U.S. Senate in the 111th Congress in producing important legislation to improve the lives of Americans, it appears that some of that body's members are looking for new things to do. In the … Continue reading
Is the Critical Path Initiative in Critical Condition? Is the Advancing Regulatory Science Initiative Replacing the Critical Path?
Does anyone remember the FDA's Critical Path Initiative (CPI)? Anyone? Does the FDA even remember the CPI? The CPI was launched six years ago in 2004 as the "FDA's national strategy for transforming the way that FDA-regulated products are … Continue reading
We wind down another week and slowly – ever so slowly – the blizzard of last week begins to disappear, though the traffic effects linger on… and on… and on. And the blizzard didn't stop the government from doing nothing … Continue reading
On February 4, Senator John McCain introduced S.3002 entitled the Dietary Supplement Safety Act of 2010. If anyone wants to introduce a topic where there should be bipartisan support, this is it. In prior sessions of Congress, Senator Dick Durbin … Continue reading