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 2022
What They Said – Looking Back the First 6-Months of FDA Communications
Periodically I write a posting to look back at what FDA is talking about to get some perspective. Each individual press release tells us something, but looking back at the aggregate can also provide insights. Not long ago, a retrospective … Continue reading
Posted in FDA Image, FDA Policy
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Here We Go Again – Monkeypox Communications Challenges
In February 2020 I published a blog posting – Emerging Pathogens, Communications – that encapsulated my observations and learnings from my years work in the early years of the HIV/AIDS pandemic in the early 1980s. As we sit, possibly, on … Continue reading
Posted in Crisis Communications, Current Affairs
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Speaking of Medicine – Mid-Year OPDP Enforcement Review
There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement … Continue reading
Posted in Uncategorized
Tagged #OPDP, #pharma
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