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: October 2012
Warning and NOV Letter Summary – 3rd Quarter 2012
Each quarter Eye on FDA examines what has occurred in enforcement by the Office of Prescription Drug Promotion (OPDP), formerly known as the Division of Drug Marketing, Advertising, and Communications (DDMAC). Apart from being instructive for those working in communications … Continue reading
Posted in Warning Letters
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Who Ya Gonna Call?
Today Mashable carried an article entitled “Twitter’s Surprising Reaction to Meningitis Outbreak” that reported that as the meningitis outbreak associated with a contaminated steroid product unfolds, users of Twitter were more often searching for CDC than FDA. The fact that … Continue reading
Posted in Drug Safety, FDA, FDA Image
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Boxed Warnings and Warning Letters
Last week I reported on some of the activities during the Food and Drug Law Institute meeting on Advertising and Promotion which I attended here in Washington, where many aspects of enforcement were discussed. I had some data I did … Continue reading
Posted in Warning Letters
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FDLI Conference on Advertisting and Promotion
The Food and Drug Law Institute held its annual conference on Advertising and Promotion for the Pharmaceutical, Medical Device, Biologic and Veterinary Medicine Industries in Washington, D.C. on October 1 and 2. I was able to attend sporadically and participated … Continue reading
Posted in FDA Policy, Medical Devices, New and Social Media
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