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: March 2020
Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 2
Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading
Principles for COVID-19 Healthcare Communications – 1 Keep it Simple, Keep it Organized
On February 21 I published a piece on LinkedIn – Communications Considerations for Medical Manufacturers as the COVID-19 Epidemic Emerges – that provided an overview of some of the communications considerations for pharma, biotech and device manufacturers related to the … Continue reading
Posted in Business/Industry News, Crisis Communications, Current Affairs, Useful Resources
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FDA Guidance on Clinical Trials During COVID-19 Pandemic
Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading
Posted in Clinical Trials, FDA Policy
Tagged #COVID-19 #coronavirus #pharma
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Impact of COVID-19 on Regulatory Enforcement and Approvals
The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading
Posted in Current Affairs, FDA Image, FDA Policy
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OPDP Issues First Letter of the Year
Hey! 2009 called. They want their Warning Letter back! Last week FDA’s Office of Prescription Drug Promotion (OPDP) posted the first letter issued for 2020 that was sent in February for the most common violation of all – related to … Continue reading
Posted in Warning Letters
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