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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Category Archives: Vitamins and Supplements
The Associated Press reported this weekend that FDA officials have expressed intent to investigate the marketing of an inhaled caffeine product. The product, called AeroShot, is described as a fine powder that is in a lip-stick type of tube … Continue reading
There are a few very specific places to look if you want to read the tea leaves of potential reforms by Congress. One is the Oversight committee correspondence with the agency that regulates your area of interest as well as … Continue reading
As reported earlier this week, S.3546 – the Dietary and Supplement and Nonprescription Drug Consumer Act was passed by the Senate on December 6. Subsequently, on December 9, the House passed the Bill by a 2-1 majority. A few minutes … Continue reading
As the lame duck Senate gets ready to waddle off to their place in history, they have moved to pass S. 3546 – a bill that would require the makers of dietary supplements to report serious adverse events. Interestingly, this … Continue reading