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: Regulatory Communications
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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Common Sense Confirmed
Common Sense Confirmed – Study Reveals Talking to the FDA is Good! – From the department of Dog Bites Man, the FDA issued a press release on February 9 revealing that pharmaceutical and biotech companies that communicate more frequently and earlier … Continue reading
Posted in Regulatory Communications
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