About the AuthorMy 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.
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 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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Category Archives: FDA
FDA OPDP Look Back at 2021 – The Yawning Gap
Once again it was a quiet year with respect to the FDA’s Office of Prescription Drug Programs (OPDP). As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from … Continue reading
Posted in DTC Advertising, FDA, FDA Policy Tagged #FDA, #OPDP, #pharma Comments Off on FDA OPDP Look Back at 2021 – The Yawning Gap
What They Said – FDA Press Releases Mid-2021
It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. It is not always an easy task because the nature of FDA’s … Continue reading
Vaccine Development and Approval in a Time of Pandemic
Sometimes in the midst of events, perspective is elusive. Today the Food and Drug Administration will hold a meeting of the Vaccines and Related Biologics Advisory Committee (VRBAC) to consider the application for an Emergency Use Authorization (EUA) submitted by … Continue reading
Posted in COVID19, FDA, FDA Image Tagged #COVID-19 #coronavirus #pharma Comments Off on Vaccine Development and Approval in a Time of Pandemic
What They Said – FDA Press Releases First Half 2019 – B.G and A.G (Before Gottlieb/After Gottlieb)
One of the many things notable during the tenure of Dr. Scott Gottlieb as FDA Commissioner was the change in communications – a change marked not just by style but substance. In fact, in a March posting here, it was … Continue reading
New Drug Approvals – A Mid-Year Assessment
During the past few years, there has been a renewed focus on facilitating the development of new medicines by providing new mechanisms to streamline the review process and get drugs to patients more quickly. The passage of the 21st Century … Continue reading
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