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: #OPDP
FDA OPDP Look Back at 2021 – The Yawning Gap
Once again it was a quiet year with respect to the FDA’s Office of Prescription Drug Programs (OPDP). As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from … Continue reading
Posted in DTC Advertising, FDA, FDA Policy Tagged #FDA, #OPDP, #pharma Comments Off on FDA OPDP Look Back at 2021 – The Yawning Gap
OPDP Sends Untitled Letter
Upfront Author’s Note: This is the first posting in a while as I have been working to migrate the subscription service to a new provider. As such, some subscribers were lost in the process. Anyone who signed up for a … Continue reading
Posted in Warning Letters Tagged #FDA, #OPDP, #pharma Comments Off on OPDP Sends Untitled Letter
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
Time for FDA’s OPDP to Fill the Gaps on Digital and Social Media
At mid-year, it has been a custom here at Eye on FDA to look back at a few categories of activity by FDA at the first half of the year and discern what it tells us about future directions. This … Continue reading
Posted in Warning Letters Tagged #OPDP Comments Off on Time for FDA’s OPDP to Fill the Gaps on Digital and Social Media