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: September 30, 2010
Insight into FDA’s Thinking on a Biosimilar Regulatory Pathway?
Today Teva Pharmaceuticals announced the receipt of a Complete Response Letter from the FDA for their Biological Licence Application (BLA) for Neutroval. Neutroval is a treatment to reduce the duration of severe neutropenia and the incidence of febrile neutropenia in … Continue reading
Posted in Biologics
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