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: #AdComm
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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Thumbs Up, Thumbs Down – Minimizing Votes in AdComms
The FDA Commissioner has said he would like to limit votes in AdComms – is that really a good idea? Continue reading
Posted in Advisory Committee Prepapartion, FDA Policy
Tagged #AdCom, #AdComm, #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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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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AdComms – Is FDA Getting Less Advice?
As more drugs are being approved, is FDA getting less advice than in the past? FDA maintains a vast network of outside advisors to provide input and counsel to the agency related to decisions on policy as well as product … Continue reading
Posted in Advisory Committee Prepapartion, FDA Image, FDA Policy
Tagged #AdCom, #AdComm, #pharma
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