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
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
Are We Moving On From Covid?
Mask mandates are dropping like flies. Restrictions are being lowered. In my observation, it feels that they are going to the wayside not only because of dropping caseloads, but also because people are just more than ready to move on. … Continue reading
Posted in FDA Image, FDA Policy Tagged #FDA Comments Off on Are We Moving On From Covid?
OPDP Issues First Regulatory Action Letter of 2022
FDA’s Office of Prescription Drug Promotion (OPDP) issued the first regulatory action letter for 2022. This one has some notable characteristics. As has been frequently noted, enforcement actions by OPDP have diminished considerably over the years. Another characteristic of recent … Continue reading
Posted in Warning Letters Tagged #FDA, #OPDP, #Untitled Letter, #Warning Letter Comments Off on OPDP Issues First Regulatory Action Letter of 2022
What They Said 2021 – An Overview of FDA Press Statements
Each year we look back to take stock of how the agency has been communicating in the course of the previous year and assess how that might compare to years gone by. In fact from year to year, there is … Continue reading
Posted in FDA Image, FDA Policy Tagged #FDA, #FDACommunications, #FDAPressReleases Comments Off on What They Said 2021 – An Overview of FDA Press Statements