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: Advisory Committee Prepapartion
FDA Launching New Advisory Committee on Digital Health
FDA announced this week the formation of a new advisory committee – the Digital Health Advisory Committee – for the purpose of providing the agency with advice on matters related to digital health technologies (DHT). FDA does not form new … Continue reading
Posted in Advisory Committee Prepapartion, Digital Health, FDA Policy
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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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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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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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