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: July 17, 2007
What’s at Stake with Formal Dispute Resolution
Recently, two pharmaceutical companies announced that they would be seeking Formal Dispute Resolution (FDR) because of FDA decisions regarding their products. Genta announced in April that the company would be filing one over a non-approvable letter for their investigative product … Continue reading
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