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: Medical Devices
Treating the Patient, Not the Symptoms – FDA and Digital Health
Last week Commissioner Scott Gottlieb delivered remarks at the Health Datapalooza, the meeting representing a nexus between innovation in digital health and the world of policy. He began his talk by saying that for most of the last century, medical … Continue reading
Posted in FDA Image, FDA Policy, Medical Devices
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The Convergence of Digital Health, Devices and Pharma
There has been a huge push in policy circles to speed innovation in medicine which is manifest in several initiatives, including most notably the 21st Century Cures Act implementation. But it would be a mistake to assess the quickening pace … Continue reading
Posted in Approval Announcements, Medical Apps, Medical Devices
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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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Expanding World of Medical Apps – Quantity and Quality
This weekend the Washington Post carried an article that, among other things, focused on the explosion of apps available in healthcare. Entitled “Health-care Apps of Smartphones Pit FDA Against Tech Industry” the primary thrust of the article was as the … Continue reading
Posted in Medical Apps, Medical Devices
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