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: May 2008
President Bush this week signed into law the Genetic Information Nondiscrimination Act (GINA) which is the "first and only" legislative effort at the federal level that will provide protections against discrimination based on an individual’s genetic information in health insurance … Continue reading
By now, you have probably heard that Google has launched a new tool called Google Health which is designed to help patients store their medical records and manage their health. I couldn’t resist being an early adapter and thought I … Continue reading
By my accounting, the FDA has just issued its fourth approvable letter so far in 2008. Compare that to 2007 when by this date, the agency had issued a whopping 12 approvable letters. And, according to an article carried on … Continue reading
For those of you who subscribe to Eye on FDA by email, there was something of a mystery yesterday involving the podcast. The link to download the podcast for some reason opened you up to the transcript of a press … Continue reading
FDA Discusses News Reports That the Agency has Withheld Information on Chinese Manufacturers of Heparin from Congress
In February 2008, the FDA announced that heparin, a blood thinning agent, was not going to be manufactured voluntarily by its U.S. manufacturer because of serious adverse events. The adverse events were tied by FDA to a contaminant discovered that … Continue reading