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.
Tag Archives: FDA
FDA’s OPDP Issues Two New Untitled Letters
While enforcement has been at a low ebb for quite some time with FDA’s Office of Prescription Drug Promotion (OPDP), this week took a different turn with the posting of two new untitled letters sent October 31. That brings the … Continue reading
Posted in OPDP, Regulatory Communications
Tagged #OPDP, #pharma, 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
Posted in Uncategorized
Tagged CrisisComms, Crisiscommunications, FDA, FDAImage
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For FDA and CDC and the Rest of Us – The Stakes Have Never Been Higher
Since last week’s posting regarding FDA credibility being on the line, there has been a swirl of activity and commentary around the evaluation of vaccine research for COVID-19 that would seem to have exacerbated the problem. For context, last week … Continue reading
Look Back – Drug Approvals First Half of 2020 Amidst the COVID Challenge
As the year began, no one really thought that within a few months, the systems upon which we rely on for just about everything would be so severely disrupted and tested by the presence of something we cannot even see … Continue reading
Posted in Approval Announcements, FDA Policy
Tagged Drug Approvals, FDA, Pharma
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AdComm Drop-off in 2019 – FDA Consults Fewer Experts in 2019
The system of FDA Advisory Committees is in place so that when FDA needs advice – either on policy development, reviewing an issue with an already approved medicine, or regarding new drug approvals – the agency has a lot of … Continue reading
Posted in Uncategorized
Tagged AdComms, Advisory Committees, Drug Approvals, FDA
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