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
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