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
My Profile
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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Legislative Tracking Tools
Category Archives: Approval Announcements
HHS Secretary Directs FDA Decision on Plan B
Plan B oral contraceptive (levonorgestrel 1.5mg), commonly known as the “morning after” pill, has been available for women over 17 for several years without a prescription. The eventual granting of non-prescription status followed a long and somewhat tortured regulatory pathway … Continue reading
Posted in Approval Announcements, FDA Policy
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The Swine Flu Vaccine is Approved – If You Build it Will They Come?
Yesterday the Food and Drug Administration announced the approval of flu vaccines for the H1N1 flu virus, popularly known as Swine Flu, being manufactured by four separate firms. The amount of time between the initial outbreaks of H1N1 this Spring, … Continue reading
Posted in Approval Announcements
2 Comments
New Prostate Cancer Treatment Approved by FDA
Ferring Pharmaceuticals is having a good month and have gotten two significant Holiday gifts, as do patients with prostate cancer. Last week, the CHMP announced approval of Ferring Pharmaceutical's new treatment for prostate cancer, Degelarix. Today, the FDA followed suit … Continue reading
Posted in Approval Announcements
1 Comment
Playing Catch-up
I took last week off for the holidays. Expecting guests, planning menus and my other regular duties left no time for posting and I suspected, little time for others to be reading. However, in spite of the holidays, things did … Continue reading
Posted in Approval Announcements, Miscellaney
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Speaking of Complete Response Letters
Here I am – speaking of Complete Response Letters. What follows is a short tutorial on the communications aspects of CRLs. NOTE ADDED OCTOBER 19, 2010 – There has lately been a great deal of interest in this … Continue reading