About the Author
My 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.
Category Archives: Warning Letters
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
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
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Tagged #OPDP, FDA Warning Letters
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2020 OPDP Enforcement
Last month we looked at a review of FDA press releases for last year and as one might have expected, there was an enormous spike in communications as a result of the COVID-19 pandemic. Looking now to a review of … Continue reading
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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
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OPDP Issues First Letter of the Year
Hey! 2009 called. They want their Warning Letter back! Last week FDA’s Office of Prescription Drug Promotion (OPDP) posted the first letter issued for 2020 that was sent in February for the most common violation of all – related to … Continue reading
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