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: September 2010
The Ever Growing FDA – Pending Regulations and Proposed Legislation
The Food and Drug Administration now regulates about one-fourth of the goods in the American economy. That's a lot of stuff. The agency oversees biologics and drugs product approvals, labeling for a slew of medical products, medical product manufacturing standards … Continue reading
Posted in Proposed Legislation
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Weekly Roundup – 09/03/10
The sun sets on a summer. Oil spills, floods, unemployment, record heat, election year politics bearing little, if any, substance – I say good riddance. Move on Summer of '10. Move on. Meanwhile, there are some more interesting things in … Continue reading
Posted in Weekly Roundup
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Qualitative Look at DDMAC NOV and Warning Letters During 1st and 2nd Quarters 2010
As reported earlier this year, the volume of regulatory action letters flowing from FDA's DDMAC continued to increase during the first half of the year at a rate that, if the trend continues, would see between 70-80 letters for the … Continue reading
Posted in Uncategorized
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