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: May 2006
FDA Credibility on the Line with RU-486
Today’s Washington Post carries news of the continued struggle over mifepristone and a renewal of effort on the part of RU-486 opponents to ban the compound because of eight deaths over the past several years. Four of these have been … Continue reading
Posted in FDA Image, FDA Policy
1 Comment
Pharma Regulatory Blog in Europe; Trends at Home
For those of you seeking an international perspective, I want to take the opportunity to introduce you to a blog developed by another lawyer, Richard Best called PharmaBlawg – Pharmaceutical Regulatory Issues on Common Law and European Countries. According to … Continue reading
Posted in Useful Resources
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Can the Administration Deliver on Bioshield?
On Friday, VaxGen shares feel 37% after it was reported that the company was going to file a legal claim against the government over its contract to produce an anthrax vaccine. First awarded in November 2004, reports this past week … Continue reading
Posted in Current Affairs
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Post-marketing Studies and Communications
Forgive me, but I am foregoing Weekly Roundup this week due to the very interesting development around post-marketing studies. In any case, nothing too exciting happened, and we will include any developments in next week’s roundup. In the meantime, the … Continue reading
Posted in Pharma Industry Image, Proposed Legislation, Weekly Roundup
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A CARE Act for the Mentally Ill
This is going to be a long posting, so either fasten your seat belt or click onwards. I worked for a long time as a lawyer on behalf of those with HIV. When I first started, it was mainly comprised … Continue reading
Posted in Mental Health, Pharma Industry Image
2 Comments