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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Author Archives: Mark Senak
The calendar says that it will be Spring next week, but it did not feel like it to me while working in the cold, windy and rainy garden in the days leading up to this change in season. However, it … Continue reading
There would seem to be a momentum for new approvals brought on by a number of circumstances, not the least of which is the fact that last year saw a record number (47) of approvals for new molecular entities (NMEs), … Continue reading
Another busy week – tried and failed to squeeze in a posting between the Weekly Roundup, but am well set up for next week. The Northeast had another Nor’easter. And yet here we are once again ready to Spring Ahead … Continue reading
Spring is definitely springing early. Buds are popping everywhere here in the mid-Atlantic region. Heck in some places, they are more than buds, they are blossoms. Still, the flu season drags on and this week Commissioner Gottlieb mentioned that it … Continue reading
In the last installment we looked at the first part of the Strategic Roadmap – Addiction which specifically focused on opioids and nicotine. However, the next part of the FDA Strategic Policy Roadmap is less specific and instead is focused … Continue reading