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: June 2018
Weekly Roundup 6.29.18
Apologies are in order for the interruption in the Weekly Roundup schedule and no postings the last few Fridays. It was partially inspired by the fact that it was a busy few weeks for me. Conversely it seemed not so … Continue reading
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A (Slight) Liberalization of Communications with Docs from FDA
What Happened. This week FDA issued a new final guidance related to communications about medical products that, while representing a slight liberalization of regulation when it comes to discussing useful information about a drug and the cleared uses for it, … Continue reading
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The Back and Forth on Safety Versus Speed and FDA
This week the Commissioner issued a statement related to the proposed modernization of the FDA’s drug review office, also the subject of a blog post by FDA’s head of the Center for Drug Evaluation and Research Janet Woodcock. While focused … Continue reading
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Weekly Roundup 6.1.18
While not the official one, the summer I knew as a kid – the one beginning after Memorial Day – has arrived. Officially I guess we have to wait a few more weeks. Once again a week without an intervening … Continue reading
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