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: April 2013
Some Digital and Social Media Guidance – FDA Regulation of Pharma Communications in a Digital Era – A White Paper
I have been working to assemble a data base of FDA/OPDP Warning and NOV letters spanning the years 2004-present, tracking activity through a number of fields. The database now includes hundreds of letters and covers nearly 1000 violations cited by … Continue reading
Posted in New and Social Media, Warning Letters
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