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: AdComms
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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AdComm Drop-off in 2019 – FDA Consults Fewer Experts in 2019
The system of FDA Advisory Committees is in place so that when FDA needs advice – either on policy development, reviewing an issue with an already approved medicine, or regarding new drug approvals – the agency has a lot of … Continue reading
Posted in Uncategorized
Tagged AdComms, Advisory Committees, Drug Approvals, FDA
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Sorting it Out – FDA AdComm Review for 2018
In 2017, the Advisory Committees voted to recommend approval 71.4 percent of the time; in 2018 it was 66.6 percent. Continue reading