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.
Monthly Archives: January 2007
The New FDA Drug Safety Initiative – Policy and Communications Implications
Yesterday the FDA announced yet another new initiative on drug safety. This is apparently in addition to the pre-existing Drug Safety Initiative. It is an action taken in response to the Institute of Medicine (IOM) report – The Future of … Continue reading
Posted in FDA Image, Risk Management, Safety and Clinical Trials
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The EMEA and the FDA
Last week, a report was issued by the Tufts Center for Drug Development that showed that while the European Medicines Agency (EMEA) – the European Union’s FDA equivalent – had met its performance goals, it was nevertheless lagging behind the … Continue reading
Posted in Miscellaney
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Weekly Roundup 1/26/07
Already the first month of the new year draws to a close. We’ve heard about the State of the Union, such that it is. The days, thankfully, grow longer. And at the FDA, there have been another huge batch of … Continue reading
Posted in Weekly Roundup
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Approvable Letter Issued to Wyeth
Following a rash of approvable letters at the end of 2006 for a number of products, Wyeth Pharmaceuticals announced that it has received an FDA approvable letter on January 22 for Pristiq (TM) – desvenlafaxine succinate – a serotonin-norepinephrine reuptake … Continue reading
Posted in Approvable Letters
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Warning Letter Summary for 4th Quarter 2006
A total of seven companies received Warning Letters during the last quarter, meaning that one-third of the year’s letters came in the final three months of the year. What we saw is a mix of large and small companies, with … Continue reading
Posted in Warning Letters
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