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 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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An Overview of FDA OPDP Enforcement for 2019
It is time to look back at enforcement for the 2019 year. It is still possible that FDA could post another letter, as there is a lag time between the time a letter is sent and the time it is … Continue reading
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Tagged FDA Enforcement, OPDP, Warning Letters
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Enforcement Update – FDA OPDP Sends Two More Letters
For those who like to keep up on the activity of the Office of Prescription Drug Promotion (OPDP) here is an update. While not shaping up to be another big year of enforcement, there has been a bit of activity … Continue reading
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FDA Sends CBD Related Warning Letter
This week FDA sent a Warning Letter to a company engaged in marketing products containing cannabidiol (CBD) to consumers for a wide variety of uses in both humans and canines. In addition to the letter, the agency underscored their action … Continue reading
Posted in CBD, FDA Policy, Warning Letters
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OPDP Sends Third Enforcement Letter of the Year
The folks at the Office of Prescription Drug Promotion (OPDP) have been in the mood lately to make a point. You can tell because they recently issued the third regulatory action letter of the year. Many years ago this would … Continue reading
Posted in FDA Policy, Warning Letters
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