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 2006
Lessons for a New Regulatory Era
Over the course of the next several days, I’m going to be writing on the many ways in which the new regulatory era is going to affect business as usual for bringing new products to market. Lesson 1 – The … Continue reading
Posted in Advisory Committee Prepapartion
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A Resource on Reimbursement – The Piper Report
For those working in or around the pharmaceutical or biologics industry, it is understood that the issues a product faces in coming to market are not confined to the FDA. In other words, while the FDA focus is strictly on … Continue reading
Posted in Useful Resources
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Alert on MedWatch Alerts!
Are drugs suddenly riskier or is the FDA suddenly more vigilant? Questions about the agency’s efficacy in protecting public health began to increase a few years back, when the ephedra issue presented itself and many critics thought that the agency … Continue reading
Posted in Risk Management
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Class of One – Avoiding Warning Letters, Part II
According to FDA regulations, one cannot state a claim that one’s drug or biologic is superior to another unless there has been a head to head study demonstrating that superiority. That regulatory reality can be frustrating to communications professionals who … Continue reading
Posted in Regulatory Communications, Warning Letters
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Sales and Warnings
During the past two years, the FDA has been repeatedly questioned in very public ways as to whether or not it is acting to protect public health. A consequence of that fact is that the agency must appear ever vigilant … Continue reading
Posted in Warning Letters
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