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
Foreign Suppliers of Pharma Products
On Sunday, two of the nation’s leading papers, the New York Times and the Washington Post both carried front page articles relating to the safety of medical products or components of medical products from China. The Times article, "FDA Tracked … Continue reading
Posted in Drug Safety
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The Congressional Hearing on Avandia
I attended the House Committee on Government Oversight and Government Reform hearing on the GlaxoSmithKline diabetes drug Avandia yesterday. It was crowded and heated, both literally and figuratively. If you are interested in watching the video of the Avandia hearing, … Continue reading
Posted in Drug Safety
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Risk Management Committee Announced; Congressional Hearing Tomorrow
Yesterday the FDA announced the formation of the Risk Communication Advisory Committee – a new 15 member committee solely dedicated to help FDA better understand the communication needs and priorities of the general public; advise FDA on the development of … Continue reading
Posted in Drug Safety
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The Senators, the FDA, the Company and The Access to Medicare Data Act of 2007
This year, Senators Charles Grassley (R-Iowa) and Max Baucus (D-Mont) have been on more of a tear than usual regarding the FDA. A lot of their focus this year has been on post-marketing surveillance of drugs and devices. They are … Continue reading
Posted in Drug Safety, Proposed Legislation
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Compare and Contrast – EMEA and FDA on Avandia
The FDA issued a press release on the issuance of a safety alert on Avandia on May 21. On May 23, the European Medicines Agency (EMEA) also released a statement on Avandia safety. I thought it interesting to compare the … Continue reading
Posted in Drug Safety, FDA Image
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