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

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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

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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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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

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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

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