About the Author
My 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.Stay Connected
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I 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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Monthly Archives: March 2007
Revising Advisory Committee Criteria
The FDA has issued a new draft guidance on Advisory Committee criteria in an attempt to quell the rising tide of criticism that advisory committee members are often too tied to industry to be rendering impartial decisions. The outline of … Continue reading
Posted in FDA Image, FDA Policy
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Get the Point About Flu Shots
Associated Press reports yesterday that on midnight of June 30, the expiration date will pass for millions of doses of flu vaccine that went unused this year and they will accordingly be destroyed. I can’t help wondering how that happens … Continue reading
Posted in Current Affairs
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Pharmacogenomics, Personalized Medicine and the Future
A lot of people might think that the term "personalized medicine" means medicine that is tailored and fashioned for your particular needs – a drug made to fit you. In fact, it is the other way around – it is … Continue reading
Posted in Current Affairs, Proposed Legislation, Tutorial
1 Comment
Why is the FDA Regulating Dog Food?
The FDA has an extraordinarily large mandate. It covers everything from makeup to pills to – you guess it, pet food. Over the weekend, (yes, the press office at FDA is open over the weekend), the agency issued a notice … Continue reading
Posted in Current Affairs
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Weekly Roundup – 3/16/07
The daffodils have pushed their little heads up and are presenting green bunches pregnant with yellow tips in flower beds all around our fair city – the crocuses are spreading little purple and yellow blossoms across the lawns. Woodpeckers are … Continue reading
Posted in Weekly Roundup
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