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: AdCom
Drug Approvals and FDA AdComms in 2023
Having passed the mid-year point, it is always an interesting exercise to take stock of where we stand with respect to the approval of new medicines. Overall, when considering the volume of activity, things would seem to be looking up … Continue reading
Posted in Advisory Committee Prepapartion, FDA Policy
Tagged #AdComm, #pharma, AdCom, AdComms
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Big Decisions – Reviewing FDA Advisory Committee Outcomes Since 2020
In January we took a look at FDA Advisory Committees (AdComms) – FDA AdComms – When the Going Gets Tough – noting, among other things that there had not only been fewer meetings but also that it appeared that the … Continue reading
Posted in Advisory Committee Prepapartion
Tagged AdCom, AdComm, AdComms, Drug Approvals, Pharma
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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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FDA Advisory Committee Review of 2021
FDA has scheduled the first advisory committee meetings of 2022. One meeting of the Oncologic Drugs Advisory Committee is set for February 10 to discuss a new application for the proposed treatment of Non-Small Cell Lung Cancer (NSCLC. And a … Continue reading
Posted in Advisory Committee Prepapartion
Tagged AdCom, AdComm
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