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
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
FDA Authorizes Third Dose – Some Implications
What does “fully vaccinated” mean today? In the face of the widening spread of the SARS-Cov-2 variant, the rise in breakthrough cases, and data that suggests a slight waning effect over time of vaccines, FDA acted yesterday to protect some … Continue reading
Posted in Uncategorized Tagged #COVID19; #coronavirus, #FDA Comments Off on FDA Authorizes Third Dose – Some Implications
What They Said – FDA Press Releases Mid-2021
It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. It is not always an easy task because the nature of FDA’s … Continue reading
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
What They Said – A Look Back at FDA Press Releases First Half of 2020
Each year, midway through it all, I take a look back to see what FDA has been talking about and compare it to the year before to see how things may have changed. I’m a little late at getting to … Continue reading