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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Monthly Archives: April 2020
The Language of “Recovery” in the Age of COVID-19
There have been many parallels drawn between this pandemic and the AIDS pandemic that began in 1981. And in fact while many obvious differences exist there are many valid comparisons. Moreover, there are some common threads that run through crises … Continue reading
Impact of COVID-19 on FDA Enforcement and Approvals – Part 5 – FDA Provides Update to Shape Expectations on New Approvals
In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading
Posted in Approval Announcements, COVID19, FDA Policy Tagged #coronavirus, #COVID19 1 Comment
T-Minus COVID-19 – Impact of Pandemic on New Medicine Launches
As the coronavirus pandemic began to unfold, focus on the pharmaceutical and biotech sectors was on the most immediate and apparent concerns – the impact on the supply chain for drugs that are currently in the market and on the … Continue reading
Posted in Approval Announcements, COVID19, Current Affairs, Pharma Industry Image Comments Off on T-Minus COVID-19 – Impact of Pandemic on New Medicine Launches
Principles for COVID-19 Healthcare Communications – 2 – The Virtual Medical Meeting
Virtually everyone is going virtual. Even in February, which seems like a very long time ago, many organizers began either postponing or canceling major conferences and meetings. This has included major medical meetings and given that large gatherings will be … Continue reading
Posted in Advisory Committee Prepapartion, Current Affairs Comments Off on Principles for COVID-19 Healthcare Communications – 2 – The Virtual Medical Meeting
Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 3 – FDA Adds Resources to Facilitate COVID-19 Research
With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading
Posted in Current Affairs, FDA Policy Comments Off on Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 3 – FDA Adds Resources to Facilitate COVID-19 Research