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. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
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 2009
February is nearly over. Traditionally, February has never been my favorite month. The short days start getting on my nerves, the weather is usually unpleasant – the brisk winds that were so refreshing in October are downright bone-chilling by February. … Continue reading
A press release used to be sent out by fax and later email. They got picked up and printed and then people who wanted to read the article in the publication might. They might clip it out and send it to … Continue reading
What? What is a 483? A 483 is the vernacular for an FDA inspection of quality standards, manufacturing or the conduct of a clinical trial, and the discovery of deficiencies therein. In other words, theygo through your manufacturing facility, for … Continue reading