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: FDA Image
What They Said – Reviewing the First 6-Months of FDA Communications
Every six months, we do a look-back to see what has changed in the way that FDA is communicating. One might not think there is much difference over time, but there is. For example, the air has pretty much gone … Continue reading
Emerging from Emergency – Two COVID-Related Developments This Week
Two announcements occurred this week, both of note and connected only by the fact that they are emblematic of the slow metamorphosis from a COVID emergency world to a post-COVID emergency one. Emergency Ends – First, the Biden Administration announced … Continue reading
Posted in FDA Image, FDA Policy
Tagged #AdComm, #COVID19, #Face-to-Face FDA Meetings, AdCom, AdComms
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What They Said – Looking Back at FDA Press Releases During 2022
Each year Eye on FDA provides a look-back to see what the agency was talking about and what has changed over time. This year is a telling one and FDA may be changing the nature of the way they are … Continue reading
Posted in FDA Image
Tagged #FDA, #FDAPressReleases
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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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Are We Moving On From Covid?
Mask mandates are dropping like flies. Restrictions are being lowered. In my observation, it feels that they are going to the wayside not only because of dropping caseloads, but also because people are just more than ready to move on. … Continue reading