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: Uncategorized
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
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Tagged #OPDP, #pharma
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New Approvals in 2022
We are at mid-year, a good time to check in and see how we are doing on a number of fronts – including where we are with new drug approvals. Over the years, Congress has acted to enhance the ability … Continue reading
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FDA Authorizes Third Dose – Some Implications
What does “fully vaccinated” mean today? In the face of the widening spread of the SARS-Cov-2 variant, the rise in breakthrough cases, and data that suggests a slight waning effect over time of vaccines, FDA acted yesterday to protect some … Continue reading
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Tagged #COVID19; #coronavirus, #FDA
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Crisis Communications and FDA
In the face of a crisis situation, it is a given that the clarity and thoroughness of the communications response is key to resolving the issue and mitigating any reputational damage. Perhaps no other decision by the Food and Drug … Continue reading
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Tagged CrisisComms, Crisiscommunications, FDA, FDAImage
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COVID-19 Vaccinations – Where a Commitment to Diversity is Essential
In my last posting on preparedness for a post-vaccination world I touched on some of the questions facing employers in general – policy questions that should be considered now for the eventualities of later. But digging a little deeper, there … Continue reading
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Tagged #COVID19
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