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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Author Archives: Mark Senak
Thumbs Up, Thumbs Down – Minimizing Votes in AdComms
The FDA Commissioner has said he would like to limit votes in AdComms – is that really a good idea? Continue reading
Posted in Advisory Committee Prepapartion, FDA Policy Tagged #AdCom, #AdComm, #pharma Leave a comment
Big Decisions – Reviewing FDA Advisory Committee Outcomes Since 2020
In January we took a look at FDA Advisory Committees (AdComms) – FDA AdComms – When the Going Gets Tough – noting, among other things that there had not only been fewer meetings but also that it appeared that the … Continue reading
Posted in Advisory Committee Prepapartion Tagged AdCom, AdComm, AdComms, Drug Approvals, Pharma Comments Off on Big Decisions – Reviewing FDA Advisory Committee Outcomes Since 2020
Emerging from Emergency – Two COVID-Related Developments This Week
Two announcements occurred this week, both of note and connected only by the fact that they are emblematic of the slow metamorphosis from a COVID emergency world to a post-COVID emergency one. Emergency Ends – First, the Biden Administration announced … Continue reading
Posted in FDA Image, FDA Policy Tagged #AdComm, #COVID19, #Face-to-Face FDA Meetings, AdCom, AdComms Comments Off on Emerging from Emergency – Two COVID-Related Developments This Week
What They Said – Looking Back at FDA Press Releases During 2022
Each year Eye on FDA provides a look-back to see what the agency was talking about and what has changed over time. This year is a telling one and FDA may be changing the nature of the way they are … Continue reading
Posted in FDA Image Tagged #FDA, #FDAPressReleases Comments Off on What They Said – Looking Back at FDA Press Releases During 2022
When the Going Gets Tough – FDA AdComms in 2022
Through its Human Drugs Advisory Committee process FDA has a vast array of outside experts to consult on matters related to product approval as well as questions about policy or safety issues concerning approved products. The mechanism provides an open … Continue reading
Posted in Advisory Committee Prepapartion Tagged #AdCom, #AdComm, #FDA, #pharma Comments Off on When the Going Gets Tough – FDA AdComms in 2022