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: August 11, 2008
Cardiome and Astellas Announce Receipt of FDA Approvable Letter for KYNAPID
Today is supposed to mark the day that the FDA quits submitting approvable letters and starts issuing "complete response letters" – but it looks like one flew off the shelf just in the nick of time – at least per … Continue reading
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Warning Letter Summary – Second Quarter 2008
Warning letters from the FDA’s DDMAC have only been at the pace of a trickle under the Bush Administration, and the second quarter was no exception, though there was at least one interesting lesson to be learned. In April, DDMAC … Continue reading
Posted in Warning Letters
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