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: August 2017
My Moment with Jay Thomas
A departure from the usual FDA fare. The blog is meant to cover FDA issues, but also various aspects of communications. This is a story about media training, sort of. Jay Thomas died yesterday. He was 69 years old. He … Continue reading
Posted in Miscellaney
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Weekly Roundup 8.11.17
I’ve decided to bring back the Weekly Roundup. I have missed it and especially now with the prospect of a good deal of change in healthcare in general and FDA in particular, much more is happening than I would ever … Continue reading
Posted in Weekly Roundup
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New FDA Directions, Part 2 – Cures Implementation
In Part 1 of FDA New Directions, we looked at the issue of pricing. Today we’re looking at implementation of the 21st Century Cures Act (the Act). Prior to becoming the FDA Commissioner, Dr. Gottlieb was a strong supporter of … Continue reading
Posted in FDA Policy
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New FDA Directions, Part 1 – Pricing
With a change in leadership at FDA there naturally a great deal of anticipation with regard to the potential for new direction for the agency and the impact it will have on the agency’s diverse stakeholders. That is especially true … Continue reading
Posted in FDA Image, FDA Policy
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