It is always a good idea to review the content of Warning and untitled letters to learn from the lessons being taught be DDMAC with respect to communications that promote the marketing of pharmaceutical, biotech and device products. However, I have been behind on reporting on the Warning and Untitled Letter updates from DDMAC and my last report was for the third quarter of 2008. But today is catch up day. Here is a report that covers the last quarter of 2008 and the first quarter of 2009, which does not include the infamous day after April Fool's Day issuance of the 14 Warning Letters on search engine ads.
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 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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