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: October 11, 2006
Tracking Approvable Letters
There are three general outcomes from submitting a new drug to the FDA for approval. First – approval, for which everyone hopes. Second non-approval, which is the obvious bad scenario. Third are approvable letters, issued by the FDA when they … Continue reading
Posted in Regulatory Communications
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