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 apparently intends to implement today an idea that has been kicking around for a while to begin publishing the names of companies that have had letters of complaint lodged against them asserting that they are taking actions to block … Continue reading
Last week Commissioner Scott Gottlieb delivered remarks at the Health Datapalooza, the meeting representing a nexus between innovation in digital health and the world of policy. He began his talk by saying that for most of the last century, medical … Continue reading
It goes without saying that enforcement by FDA’s Office of Prescription Drug Promotion (OPDP) as identified through regulatory action letters (warning or untitled) over the past few years is a mere shadow of its former self. Enforcement was once robust, … Continue reading
FDA has had a lot to say so far this year. A real lot. In fact, during the first three months of 2018, FDA issued 56 press releases, which is as many as they issued during the entire first half … 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