About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in Washington D.C. 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.
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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Category Archives: Approval Announcements
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
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
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
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