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.
Posts by Date
Legislative Tracking Tools
Monthly Archives: March 2021
Passport Please – An App to Verify Your Status in a World Re-Shaped by COVID-19
This week New York became the first state to make available a means for mobile digital confirmation that an individual has been vaccinated for COVID-19. Popularly known as “immunity passports” they are in fact more than that. The New York … Continue reading
Posted in COVID19, Current Affairs Tagged #COVID-19 #coronavirus #pharma Comments Off on Passport Please – An App to Verify Your Status in a World Re-Shaped by COVID-19
“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
OPDP Warning and Untitled Letters – A Separation; a New Letter from OPDP
This is sort of a two-for posting. First we will look at a change in how FDA is reporting regulatory actions by OPDP on the FDA website, and second we will cover the most recent such action. OPDP Warning Letter … Continue reading
Posted in Warning Letters Tagged #OPDP, FDA Warning Letters Comments Off on OPDP Warning and Untitled Letters – A Separation; a New Letter from OPDP