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: January 2023
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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When the Going Gets Tough – FDA AdComms in 2022
Through its Human Drugs Advisory Committee process FDA has a vast array of outside experts to consult on matters related to product approval as well as questions about policy or safety issues concerning approved products. The mechanism provides an open … Continue reading
Posted in Advisory Committee Prepapartion
Tagged #AdCom, #AdComm, #FDA, #pharma
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