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.
Daily Archives: January 6, 2015
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
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