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: February 2012
Weekly Roundup – 2/24/12
I have been super-busy, as you may have discerned from my recent lack of correspondence here. But I am not alone! Things have been hopping from the FDA perspective, and here are a few things that occurred this week that … Continue reading
Posted in Weekly Roundup
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FDA to Examine Inhaled Caffeine
The Associated Press reported this weekend that FDA officials have expressed intent to investigate the marketing of an inhaled caffeine product. The product, called AeroShot, is described as a fine powder that is in a lip-stick type of tube … Continue reading
Posted in FDA Policy, Vitamins and Supplements
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Warning and NOV Letter Summary – 4th Quarter 2011
Each quarter Eye on FDA provides a brief recap of the regulatory action letters issued respecting the promotion of prescription drugs. The office that issues the letter underwent a change during 2011, changing its name in the process from the … Continue reading
Posted in Warning Letters
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Weekly Roundup 2/10/12
Another snowless week, even when snow was predicted leads one to speculate that the daffodils, pushing their heads up so early, might not bloom just in time to have their heads poking up in a freakishly late blizzard. Meanwhile Valentine’s … Continue reading
Posted in Weekly Roundup
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NIH Clinical Trials and You
For a long time, I have thought that clinical trial information was too clinical to be of much use for patients who might be considering entering one. The information available was either in the form of searchable data bases, text … Continue reading
Posted in Clinical Trials
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