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.
Monthly Archives: January 2015
Weekly Roundup 1.9.15
The New Year has gotten off to a very chilly start here in Washington, D.C. But we have a new Congress that has been sworn in as the 114th. I have cleared the Eye on FDA tab on the blog … Continue reading
Posted in Weekly Roundup
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Warning and NOV Letters Plummet in 2014
There are two types of letters issued by FDA’s Office of Prescription Drug Promotion (OPDP) related to its role in regulating the commercial speech of medical product manufacturers – Warning Letters (WLs) and Notice of Violation (NOV) letters. One can … Continue reading
Posted in Warning Letters
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Biggest 2014 FDA Stories
Of course, it is entirely a subjective matter to pick out the most interesting stories of the year. When it comes to an agency that oversees the regulation of one-quarter of the U.S. economy spanning everything from medicines to cosmetics … Continue reading
Posted in Current Affairs, FDA Image
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