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: FDA Policy
FDA ended the year quietly and began the new year in similar fashion. The holidays are of course a factor, but in all of October and November of 2016, there were only 3 releases issued for each month. Even in … Continue reading
In Part 1 about change facing FDA, we looked at the 21st Century Cures Act and some of the change that would be in store for FDA. But in this post-election cycle, there is more than pending legislation that could … Continue reading
One of the often stated priorities for lame-duck Congress has been voting on the 21st Century Cures Act. In a press release from Saturday, November 26 from the House Energy and Commerce Committee, the House is set to vote on … Continue reading
In recent years FDA has undertaken several means to facilitate the consideration of new drug applications by creating various mechanisms for expedited review for either new drugs or new indications for existing drugs. Prior to 2012, there had long been … Continue reading