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.
Category Archives: Drug Safety
Risk Management Workshop
The FDA is scheduled to announce today a Risk Management Workshop designed to discuss such programs and share information among key stekholders. Risk Management has been an increasing source of concentration in the post-COX-2 era. There were compounds prior to … Continue reading
Posted in Drug Safety, Risk Management
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Congressional Hearing on FDA’s Handling of Avandia
I don’t know what the record is for announcing a Congressional investigation after breaking news, but the title may go to Congressman Henry Waxman (D-CA), under whose feet no grass grows. I think he may hold the record. There has … Continue reading
Posted in Drug Safety, FDA Image, Industry Image
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Who’s in Favor of Safer Drugs?
The answer is probably simple. The answer is probably everyone. I think all can agree on that. This week, as PDUFA is being discussed on the Hill, Consumer Reports released a poll of approximately 1000 individuals in a phone … Continue reading
Posted in Drug Safety
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