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: Advisory Committee Prepapartion
Virtual Reality – FDA and AdComms
Vaccination has been robust. Cities are opening up. Plans are underway for back-to-school. Travel is robust. Offices are cautiously re-opening. There are multiple hallmarks that, whatever the consequences, we are going back to normal. The age of COVID-19 will likely … Continue reading
Posted in Advisory Committee Prepapartion, COVID19, Current Affairs Tagged #AdCom, #AdComm, COVID19 Comments Off on Virtual Reality – FDA and AdComms
“Can You Hear Me?” – The (Hopefully) Coming Transition from Virtual Meetings
Today, FDA published notice in the Federal Register of an upcoming meeting of the Arthritis Drugs Advisory Committee that will be held May 6. The meeting will be held virtually. Last year when the pandemic reality started setting in, like … Continue reading
Posted in Advisory Committee Prepapartion, Current Affairs Tagged #AdCom, #AdComm, COVID19 Comments Off on “Can You Hear Me?” – The (Hopefully) Coming Transition from Virtual Meetings
Approvals in the Crazy Year of 2020
Each year in January, it is relevant to look back on the activities of FDA during the course of the previous year and look at how it was the same or different from prior years, and to look at trends … Continue reading
Posted in Advisory Committee Prepapartion, FDA Image, FDA Policy Tagged #pharma, Drug Approvals Comments Off on Approvals in the Crazy Year of 2020
FDA AdComm Agenda Covers the Bases
First of all, we are having a bit of a crisis with our crisis. As we appear to be moving into yet another wave of COVID-19 infections, and as research into a vaccine is aggressively underway, we also see serious … Continue reading
Posted in Advisory Committee Prepapartion, COVID19, Current Affairs, FDA Image, FDA Policy Tagged #COVID19 Comments Off on FDA AdComm Agenda Covers the Bases
FDA to Hold Virtual AdComm
I don’t usually publish the scheduling of an AdComm with a blog posting. But this one merits one. With fewer than the usual minimum of fifteen days’ notice, FDA has scheduled an FDA Advisory Committee meeting of the Cardiovascular and … Continue reading
Posted in Advisory Committee Prepapartion, FDA Image, FDA Policy Tagged #AdCom, #AdComm, #FDAAdvisoryCommittee Comments Off on FDA to Hold Virtual AdComm