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

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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

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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

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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

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