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: COVID19
Virtual Reality – FDA and AdComms
Vaccination has been robust. Cities are opening up. Plans are underway for back-to-school. Travel is robust. Offices are cautiously re-opening. There are multiple hallmarks that, whatever the consequences, we are going back to normal. The age of COVID-19 will likely … Continue reading
Posted in Advisory Committee Prepapartion, COVID19, Current Affairs
Tagged #AdCom, #AdComm, COVID19
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Passport Please – An App to Verify Your Status in a World Re-Shaped by COVID-19
This week New York became the first state to make available a means for mobile digital confirmation that an individual has been vaccinated for COVID-19. Popularly known as “immunity passports” they are in fact more than that. The New York … Continue reading
Posted in COVID19, Current Affairs
Tagged #COVID-19 #coronavirus #pharma
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Vaccine Development and Approval in a Time of Pandemic
Sometimes in the midst of events, perspective is elusive. Today the Food and Drug Administration will hold a meeting of the Vaccines and Related Biologics Advisory Committee (VRBAC) to consider the application for an Emergency Use Authorization (EUA) submitted by … Continue reading
Posted in COVID19, FDA, FDA Image
Tagged #COVID-19 #coronavirus #pharma
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FDA AdComm Agenda Covers the Bases
First of all, we are having a bit of a crisis with our crisis. As we appear to be moving into yet another wave of COVID-19 infections, and as research into a vaccine is aggressively underway, we also see serious … Continue reading
Posted in Advisory Committee Prepapartion, COVID19, Current Affairs, FDA Image, FDA Policy
Tagged #COVID19
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The OK for Patients’ Return to Healthcare Needs Clear Signals From Trusted Sources
COVID-19 was a shock to the system unlike anything that had been anticipated. Even prior to the shutdown, health-perceptive people were starting to avoid public venues and there were declines in the numbers of people going out to eat at … Continue reading
Posted in COVID19, Current Affairs
Tagged #COVID19, coronavirus
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