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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Tag Archives: FDA
Crisis Communications and FDA
In the face of a crisis situation, it is a given that the clarity and thoroughness of the communications response is key to resolving the issue and mitigating any reputational damage. Perhaps no other decision by the Food and Drug … Continue reading
Posted in Uncategorized Tagged CrisisComms, Crisiscommunications, FDA, FDAImage Comments Off on Crisis Communications and FDA
For FDA and CDC and the Rest of Us – The Stakes Have Never Been Higher
Since last week’s posting regarding FDA credibility being on the line, there has been a swirl of activity and commentary around the evaluation of vaccine research for COVID-19 that would seem to have exacerbated the problem. For context, last week … Continue reading
Look Back – Drug Approvals First Half of 2020 Amidst the COVID Challenge
As the year began, no one really thought that within a few months, the systems upon which we rely on for just about everything would be so severely disrupted and tested by the presence of something we cannot even see … Continue reading
Posted in Approval Announcements, FDA Policy Tagged Drug Approvals, FDA, Pharma Comments Off on Look Back – Drug Approvals First Half of 2020 Amidst the COVID Challenge
AdComm Drop-off in 2019 – FDA Consults Fewer Experts in 2019
The system of FDA Advisory Committees is in place so that when FDA needs advice – either on policy development, reviewing an issue with an already approved medicine, or regarding new drug approvals – the agency has a lot of … Continue reading
Posted in Uncategorized Tagged AdComms, Advisory Committees, Drug Approvals, FDA Comments Off on AdComm Drop-off in 2019 – FDA Consults Fewer Experts in 2019